Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2019 | Oct. 28, 2019 | |
Cover page. | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2019 | |
Document Transition Report | false | |
Entity File Number | 001-10865 | |
Entity Registrant Name | AMAG Pharmaceuticals, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 04-2742593 | |
Entity Address, Address Line One | 1100 Winter Street, | |
Entity Address, City or Town | Waltham, | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02451 | |
City Area Code | 617 | |
Local Phone Number | 498-3300 | |
Title of 12(b) Security | Common Stock, par value $0.01 per share | |
Trading Symbol | AMAG | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding (in shares) | 33,915,766 | |
Entity Central Index Key | 0000792977 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 119,800 | $ 253,256 |
Marketable securities | 71,744 | 140,915 |
Accounts receivable, net | 77,588 | 75,347 |
Inventories | 28,644 | 26,691 |
Prepaid and other current assets | 43,063 | 18,961 |
Note receivable | 0 | 10,000 |
Total current assets | 340,839 | 525,170 |
Property and equipment, net | 7,912 | 7,521 |
Goodwill | 422,513 | 422,513 |
Intangible assets, net | 187,577 | 217,033 |
Operating lease right-of-use asset | 6,642 | |
Deferred tax assets | 630 | 1,260 |
Restricted cash | 495 | 495 |
Other long-term assets | 0 | 1,467 |
Total assets | 966,608 | 1,175,459 |
Current liabilities: | ||
Accounts payable | 26,554 | 14,487 |
Accrued expenses | 172,285 | 129,537 |
Current portion of convertible notes, net | 0 | 21,276 |
Current portion of operating lease liability | 3,994 | |
Current portion of deferred revenue | 1,128 | 0 |
Current portion of acquisition-related contingent consideration | 113 | 144 |
Total current liabilities | 204,074 | 165,444 |
Long-term liabilities: | ||
Convertible notes, net | 273,124 | 261,933 |
Long-term operating lease liability | 3,344 | |
Long-term deferred revenue | 5,171 | 0 |
Long-term acquisition-related contingent consideration | 180 | 215 |
Other long-term liabilities | 87 | 1,212 |
Total liabilities | 485,980 | 428,804 |
Commitments and contingencies (Note P) | ||
Stockholders’ equity: | ||
Preferred stock, par value $0.01 per share, 2,000,000 shares authorized; none issued | 0 | 0 |
Common stock, par value $0.01 per share, 117,500,000 shares authorized; 33,915,509 and 34,606,760 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively | 339 | 346 |
Additional paid-in capital | 1,292,458 | 1,292,736 |
Accumulated other comprehensive loss | (3,199) | (3,985) |
Accumulated deficit | (808,970) | (542,442) |
Total stockholders’ equity | 480,628 | 746,655 |
Total liabilities and stockholders’ equity | $ 966,608 | $ 1,175,459 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2019 | Dec. 31, 2018 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized (in shares) | 2,000,000 | 2,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 117,500,000 | 117,500,000 |
Common stock, shares issued (in shares) | 33,915,509 | 34,606,760 |
Common stock, shares outstanding (in shares) | 33,915,509 | 34,606,760 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Revenues: | ||||
Revenues | $ 84,131 | $ 122,238 | $ 238,043 | $ 385,881 |
Costs and expenses: | ||||
Cost of product sales | 21,105 | 46,489 | 63,871 | 187,176 |
Research and development expenses | 15,330 | 10,133 | 48,377 | 32,635 |
Acquired in-process research and development | 0 | 12,500 | 74,856 | 32,500 |
Selling, general and administrative expenses | 65,720 | 72,451 | 217,727 | 161,780 |
Impairment of intangible assets | 0 | 0 | 77,358 | 0 |
Restructuring expenses | 0 | 0 | 7,420 | 0 |
Total costs and expenses | 102,155 | 141,573 | 489,609 | 414,091 |
Operating loss | (18,024) | (19,335) | (251,566) | (28,210) |
Other income (expense): | ||||
Interest expense | (6,419) | (13,366) | (19,199) | (45,400) |
Loss on debt extinguishment | 0 | (35,922) | 0 | (35,922) |
Interest and dividend income | 840 | 1,612 | 3,650 | 3,207 |
Gains on marketable securities, net | 263 | 0 | 263 | 0 |
Other income (expense) | (45) | (19) | 298 | (63) |
Total other expense, net | (5,361) | (47,695) | (14,988) | (78,178) |
Loss from continuing operations before income taxes | (23,385) | (67,030) | (266,554) | (106,388) |
Income tax expense (benefit) | 232 | (2,352) | (26) | 42,204 |
Net loss from continuing operations | (23,617) | (64,678) | (266,528) | (148,592) |
Discontinued operations: | ||||
Income from discontinued operations | 0 | 5,838 | 0 | 18,873 |
Gain on sale of CBR business | 0 | 89,581 | 0 | 89,581 |
Income tax (benefit) expense | 0 | (98) | 0 | 3,346 |
Net income from discontinued operations | 0 | 95,517 | 0 | 105,108 |
Net (loss) income | $ (23,617) | $ 30,839 | $ (266,528) | $ (43,484) |
Basic and diluted net (loss) income per share: | ||||
Loss from continuing operations (in dollars per share) | $ (0.70) | $ (1.88) | $ (7.83) | $ (4.33) |
Income from discontinued operations (in dollars per share) | 0 | 2.77 | 0 | 3.06 |
Basic and diluted net (loss) income per share (in dollars per share) | $ (0.70) | $ 0.89 | $ (7.83) | $ (1.27) |
Weighted average shares outstanding used to compute net (loss) per share (basic and diluted) (in shares) | 33,906 | 34,492 | 34,058 | 34,339 |
Product Sales | ||||
Revenues: | ||||
Revenues | $ 84,107 | $ 122,238 | $ 237,812 | $ 385,806 |
Other revenues | ||||
Revenues: | ||||
Revenues | $ 24 | $ 0 | $ 231 | $ 75 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Statement of Comprehensive Income [Abstract] | ||||
Net (loss) income | $ (23,617) | $ 30,839 | $ (266,528) | $ (43,484) |
Other comprehensive loss: | ||||
Holding (losses) gains associated with marketable securities arising during period, net of tax | (167) | 134 | 786 | (253) |
Total comprehensive (loss) income | $ (23,784) | $ 30,973 | $ (265,742) | $ (43,737) |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2017 | 34,083,112 | ||||
Beginning balance at Dec. 31, 2017 | $ 790,244 | $ 341 | $ 1,271,628 | $ (3,908) | $ (477,817) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net shares issued in connection with the exercise of stock options and vesting of restricted stock units, net of withholdings (in shares) | 439,845 | ||||
Net shares issued in connection with the exercise of stock options and vesting of restricted stock units, net of withholdings | 4 | $ 4 | |||
Non-cash equity based compensation | 14,599 | 14,599 | |||
Unrealized gains (losses) on securities, net of tax | (253) | (253) | |||
Net loss | (43,484) | (43,484) | |||
Ending balance (in shares) at Sep. 30, 2018 | 34,522,957 | ||||
Ending balance at Sep. 30, 2018 | 762,246 | $ 345 | 1,286,227 | (4,161) | (520,165) |
Beginning balance (in shares) at Jun. 30, 2018 | 34,390,068 | ||||
Beginning balance at Jun. 30, 2018 | 726,903 | $ 344 | 1,281,858 | (4,295) | (551,004) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net shares issued in connection with the exercise of stock options and vesting of restricted stock units, net of withholdings (in shares) | 132,889 | ||||
Net shares issued in connection with the exercise of stock options and vesting of restricted stock units, net of withholdings | 893 | $ 1 | 892 | ||
Non-cash equity based compensation | 3,477 | 3,477 | |||
Unrealized gains (losses) on securities, net of tax | 134 | 134 | |||
Net loss | 30,839 | 30,839 | |||
Ending balance (in shares) at Sep. 30, 2018 | 34,522,957 | ||||
Ending balance at Sep. 30, 2018 | $ 762,246 | $ 345 | 1,286,227 | (4,161) | (520,165) |
Beginning balance (in shares) at Dec. 31, 2018 | 34,606,760 | 34,606,760 | |||
Beginning balance at Dec. 31, 2018 | $ 746,655 | $ 346 | 1,292,736 | (3,985) | (542,442) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net shares issued in connection with the exercise of stock options and vesting of restricted stock units, net of withholdings (in shares) | 278,474 | ||||
Net shares issued in connection with the exercise of stock options and vesting of restricted stock units, net of withholdings | (1,787) | $ 3 | (1,790) | ||
Issuance of common stock under employee stock purchase plan (in shares) | 105,075 | ||||
Issuance of common stock under employee stock purchase plan | 851 | $ 1 | 850 | ||
Repurchase of common stock pursuant to the 2016 share repurchase program (in shares) | (1,074,800) | ||||
Repurchase of common stock pursuant to the share repurchase program | (13,730) | $ (11) | (13,719) | ||
Non-cash equity based compensation | 14,381 | 14,381 | |||
Unrealized gains (losses) on securities, net of tax | 786 | 786 | |||
Net loss | $ (266,528) | (266,528) | |||
Ending balance (in shares) at Sep. 30, 2019 | 33,915,509 | 33,915,509 | |||
Ending balance at Sep. 30, 2019 | $ 480,628 | $ 339 | 1,292,458 | (3,199) | (808,970) |
Beginning balance (in shares) at Jun. 30, 2019 | 33,899,954 | ||||
Beginning balance at Jun. 30, 2019 | 499,507 | $ 339 | 1,287,553 | (3,032) | (785,353) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net shares issued in connection with the exercise of stock options and vesting of restricted stock units, net of withholdings (in shares) | 15,555 | ||||
Net shares issued in connection with the exercise of stock options and vesting of restricted stock units, net of withholdings | (69) | (69) | |||
Non-cash equity based compensation | 4,974 | 4,974 | |||
Unrealized gains (losses) on securities, net of tax | (167) | (167) | |||
Net loss | $ (23,617) | (23,617) | |||
Ending balance (in shares) at Sep. 30, 2019 | 33,915,509 | 33,915,509 | |||
Ending balance at Sep. 30, 2019 | $ 480,628 | $ 339 | $ 1,292,458 | $ (3,199) | $ (808,970) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Cash flows from operating activities: | ||
Net loss | $ (266,528) | $ (43,484) |
Adjustments to reconcile net loss to net cash (used in) provided by operating activities: | ||
Depreciation and amortization | 13,871 | 158,002 |
Impairment of intangible assets | 77,358 | 0 |
Provision for bad debt expense | (12) | 754 |
Amortization of premium/discount on purchased securities | (64) | 96 |
Write-down of inventory | 4,872 | 0 |
Gain on disposal of fixed assets | 0 | (99) |
Non-cash equity-based compensation expense | 14,381 | 14,599 |
Non-cash IPR&D expense | 18,029 | 0 |
Loss on debt extinguishment | 0 | 35,922 |
Amortization of debt discount and debt issuance costs | 11,332 | 11,824 |
Gains on marketable securities, net | (263) | (1) |
Change in fair value of contingent consideration | (16) | (49,175) |
Deferred income taxes | 408 | 43,747 |
Gain on sale of the CBR business | 0 | (89,581) |
Transaction costs | 0 | (14,111) |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | (2,229) | 7,175 |
Inventories | (6,824) | 3,587 |
Prepaid and other current assets | (24,075) | 1,101 |
Accounts payable and accrued expenses | 53,092 | (4,280) |
Deferred revenues | (101) | 8,658 |
Other assets and liabilities | 1,038 | 159 |
Net cash (used in) provided by operating activities | (105,731) | 84,893 |
Cash flows from investing activities: | ||
Proceeds from sales or maturities of marketable securities | 85,321 | 60,146 |
Purchase of marketable securities | (14,815) | (64,400) |
Purchase of developed technology | (60,000) | 0 |
Proceeds from the sale of the CBR business | 0 | 519,303 |
Capital expenditures | (2,098) | (1,913) |
Net cash provided by investing activities | 8,408 | 513,136 |
Cash flows from financing activities: | ||
Long-term debt principal payments | 0 | (475,000) |
Payments to settle convertible notes | (21,417) | 0 |
Payment of premium on debt extinguishment | 0 | (28,054) |
Payments of contingent consideration | (50) | (87) |
Payments for repurchases of common stock | (13,730) | 0 |
Proceeds from the issuance of common stock under the ESPP | 851 | 0 |
Proceeds from the exercise of common stock options | 30 | 2,635 |
Payments of employee tax withholding related to equity-based compensation | (1,817) | (2,632) |
Net cash used in financing activities | (36,133) | (503,138) |
Net (decrease) increase in cash, cash equivalents, and restricted cash | (133,456) | 94,891 |
Cash, cash equivalents, and restricted cash at beginning of the period | 253,751 | 192,770 |
Cash, cash equivalents, and restricted cash at end of the period | 120,295 | 287,661 |
Supplemental data for cash flow information: | ||
Cash paid for taxes | 456 | 5,041 |
Cash paid for interest | 5,467 | 43,546 |
Non-cash investing and financing activities: | ||
Settlement of note receivable in connection with Perosphere acquisition | $ 10,000 | $ 0 |
Description of Business
Description of Business | 9 Months Ended |
Sep. 30, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business | DESCRIPTION OF BUSINESS AMAG Pharmaceuticals, Inc., a Delaware corporation, was founded in 1981. We are a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs by leveraging our development and commercial expertise to invest in and grow our pharmaceutical products across a range of therapeutic areas. Our currently marketed products support the health of patients in the areas of maternal and women’s health, anemia management and cancer supportive care, including Feraheme ® (ferumoxytol injection) for intravenous use, Makena ® (hydroxyprogesterone caproate injection) auto-injector, Intrarosa ® (prasterone) vaginal inserts and MuGard ® Mucoadhesive Oral Wound Rinse. On June 21, 2019, Vyleesi™ (bremelanotide injection) was approved by the U.S. Food and Drug Administration (the “FDA”) for the treatment of acquired, generalized hypoactive sexual desire disorder (“HSDD”) in premenopausal women and became commercially available in September 2019. In addition to our approved products, our portfolio includes two product candidates, AMAG-423 (digoxin immune fab (ovine)), which is being studied for the treatment of severe preeclampsia, and ciraparantag, which is being studied as an anticoagulant reversal agent. In January 2019, we acquired Perosphere Pharmaceuticals Inc. (“Perosphere”) through the merger of our wholly-owned subsidiary, Magellan Merger Sub, Inc., a Delaware corporation, with and into Perosphere, with Perosphere continuing as the surviving entity and our wholly-owned subsidiary (the “Merger”). As a result of the acquisition of Perosphere, we acquired the global rights to ciraparantag, an anticoagulant reversal agent, which is being investigated for patients treated with novel oral anticoagulants or low molecular weight heparin when reversal of the anticoagulant effect of these products is needed for emergency surgery, urgent procedures or due to life-threatening or uncontrolled bleeding. See Note Q, “ Acquisitions, Collaboration, License and Other Strategic Agreements ” for further details on the Perosphere acquisition. |
Basis of Presentation and Summa
Basis of Presentation and Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Summary of Significant Accounting Policies | BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation These condensed consolidated financial statements are unaudited and, in the opinion of management, include all adjustments necessary for a fair statement of our financial position and results of operations for the interim periods presented. Such adjustments consisted only of normal recurring items. The year-end condensed consolidated balance sheet data was derived from audited financial statements, but does not include all disclosures required by accounting principles generally accepted in the United States of America (“GAAP”). In accordance with GAAP for interim financial reports and the instructions for Form 10-Q and the rules of the Securities and Exchange Commission, certain information and footnote disclosures normally included in annual financial statements have been condensed or omitted. Our accounting policies are described in the Notes to the Consolidated Financial Statements in our Annual Report on Form 10-K for the year ended December 31, 2018 (our “Annual Report”). Interim results are not necessarily indicative of the results of operations for the full year. These interim financial statements should be read in conjunction with our Annual Report. In August 2018, we completed the sale of our wholly-owned subsidiary, CBR Acquisition Holdings Corp, and the Cord Blood Registry ® (“CBR”) business to GI Partners (“GI”), a private equity investment firm, pursuant to the June 14, 2018 Stock Purchase Agreement between us and affiliates of GI. As of June 30, 2018, our CBR business met the criteria for classification as a discontinued operation. All historical operating results for CBR are therefore reflected within discontinued operations in the consolidated statements of operations for the three and nine months ended September 30, 2018. For additional information, see Note C, “ Discontinued Operations. ” Principles of Consolidation The accompanying condensed consolidated financial statements include our accounts and the accounts of our wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Use of Estimates and Assumptions The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make certain estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and the related disclosure of contingent assets and liabilities. The most significant estimates and assumptions are used to determine amounts and values of, but are not limited to: revenue recognition related to product and collaboration revenue; product sales allowances and accruals; allowance for doubtful accounts; marketable securities; inventory; acquisition date fair value and subsequent fair value estimates used to assess impairment of long-lived assets, including goodwill, in-process research and development (“IPR&D”) and other intangible assets; contingent consideration; debt obligations; certain accrued liabilities, including clinical trial accruals; income taxes, inclusive of valuation allowances; and equity-based compensation expense. Actual results could differ materially from those estimates. Restricted Cash We classified $0.5 million of our cash as restricted cash, a non-current asset on the balance sheet, as of September 30, 2019 and December 31, 2018 . This amount represented the security deposit delivered to the landlord of our Waltham, Massachusetts headquarters in the form of an irrevocable letter of credit. Concentrations and Significant Customer Information Financial instruments which potentially subject us to concentrations of credit risk consist principally of cash and cash equivalents, marketable securities, and accounts receivable. We currently hold our excess cash primarily in institutional money market funds, corporate debt securities, U.S. treasury and government agency securities and certificates of deposit. As of September 30, 2019 , we did not have a material concentration in any single investment. Our operations are located entirely within the U.S. We focus primarily on developing, manufacturing, and commercializing our products and product candidates. We perform ongoing credit evaluations of our customers and generally do not require collateral. The following table sets forth customers who represented 10% or more of our total revenues for the three and nine months ended September 30, 2019 and 2018 : Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 McKesson Corporation 38 % 25 % 37 % 26 % AmerisourceBergen Drug Corporation 28 % 24 % 28 % 26 % Cardinal Health 11 % <10% 12 % <10% Our net accounts receivable primarily represent amounts due for products sold directly to wholesalers, distributors, specialty pharmacies, and our former authorized generic partner. Accounts receivable for our products are recorded net of reserves for estimated chargeback obligations, prompt payment discounts and any allowance for doubtful accounts. At September 30, 2019 and December 31, 2018 , two and three customers, respectively, accounted for 10% or more of our accounts receivable balances, representing approximately 70% and 73% in the aggregate of our total accounts receivable, respectively. We are currently dependent on a single supplier for Feraheme drug substance (produced in two separate facilities) as well as a single supplier for our Makena auto-injector product. We have been and may continue to be exposed to a significant loss of revenue from the sale of our products in the event that our suppliers and/or manufacturers are not able to fulfill demand for any reason. Revenue Recognition Product revenues Effective January 1, 2018, we adopted the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”), using the modified retrospective transition method. Under ASC 606, we recognize revenue when our customer obtains control of promised goods or services in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of ASC 606, we perform the following five steps: a. Identify the contract(s) with a customer; b. Identify the performance obligations in the contract; c. Determine the transaction price; d. Allocate the transaction price to the performance obligations in the contract; and e. Recognize revenue when (or as) the performance obligations are satisfied. We only apply the five-step model to contracts when it is probable that we will collect the consideration we are entitled to in exchange for the goods or services we transfer to the customer. At contract inception, if the contract is determined to be within the scope of ASC 606, we assess the goods or services promised within each contract, determine those that are performance obligations, and assess whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Collaboration Revenues When we enter into collaboration agreements, we assess whether the agreements fall within the scope of ASC Topic 808, Collaborative Arrangements (“ASC 808”) based on whether the arrangements involve joint operating activities and whether both parties have active participation in the arrangement and are exposed to significant risks and rewards. To the extent that the arrangement falls within the scope of ASC 808, we assess whether the payments between us and our collaboration partner fall within the scope of other accounting literature. If we conclude that payments from the collaboration partner to us represent consideration from a customer, such as license fees and contract research and development activities, we account for those payments within the scope of ASC 606. However, if we conclude that our collaboration partner is not a customer for certain activities and associated payments, such as for certain collaborative research, development, manufacturing and commercial activities, we present such payments as a reduction of research and development expense or general and administrative expense, based on where we present the related underlying expense. Leases Effective January 1, 2019, we adopted ASC Topic 842, Leases (“ASC 842”), and chose to apply the provisions of ASC 842 as of the effective date with no restatement of prior periods or cumulative adjustment to retained earnings. Upon adoption, we elected to utilize the package of transition practical expedients, which allowed us to carry forward prior conclusions related to whether any expired or existing contracts are or contain leases, the lease classification for any expired or existing leases and initial direct costs for existing leases. We also made accounting policy elections to not separate lease and non-lease components for our real estate lease and to not recognize leases with an initial term of twelve months or less within our condensed consolidated balance sheets and to recognize those lease payments on a straight-line basis on our condensed consolidated statements of income over the lease term. We did not have any material short-term leases accounted for under this policy during the six months ended September 30, 2019 . We determine if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets, current portion of operating lease liability, and long-term operating lease liability on our condensed consolidated balance sheets. ROU assets represent our right to use an underlying asset for the lease term and operating lease liabilities represent our obligation to make lease payments arising from the lease. ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at the commencement date. As our leases do not provide an implicit rate, we use our incremental borrowing rate based on the information available at the commencement date in determining the present value of future payments. Our incremental borrowing rate is determined based on an evaluation of our creditworthiness and the prevailing market rates for collateralized debt with maturity dates commensurate with the term of each lease. Our lease terms may include options to extend or terminate the lease when it is reasonably certain that we will exercise the option. Lease expense for operating leases is recognized on a straight-line basis over the lease term. The lease payments used to determine our ROU assets may include lease incentives, stated rent increases, and escalation clauses linked to rates of inflation when determinable and are recognized in our ROU assets on our condensed consolidated balance sheet. In addition, certain lease agreements contain lease and non-lease components. With the exception of our real estate leases, we separate lease payments for the identified assets from any non-lease payments included in the agreement. For our real estate leases, we account for the lease and non-lease components as a single lease component. Additionally, for vehicle and certain equipment leases, we apply a portfolio approach to effectively account for the related ROU assets and operating lease liabilities. Reclassifications Certain prior period amounts have been reclassified to conform to the current period presentation. |
Discontinued Operations
Discontinued Operations | 9 Months Ended |
Sep. 30, 2019 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Discontinued Operations | DISCONTINUED OPERATIONS On August 6, 2018, we completed the sale of our CBR business to GI Partners pursuant to the CBR Purchase Agreement. We determined that the sale of CBR represented a strategic shift that would have a major effect on our business and therefore met the criteria for classification as discontinued operations at June 30, 2018. All historical operating results for CBR were reflected within discontinued operations in the condensed consolidated statement of operations for the three and nine months ended September 30, 2018 . The following is a summary of net income from discontinued operations for the three and nine months ended September 30, 2018 : Three Months Ended September 30, 2018 Nine Months Ended September 30, 2018 Service revenues, net $ 12,163 $ 71,217 Costs and expenses: Cost of services 1,576 12,559 Selling, general and administrative expenses 4,749 39,899 Total costs and expenses 6,325 52,458 Operating income 5,838 18,759 Other income — 114 Income from discontinued operations 5,838 18,873 Gain on sale of CBR business 89,581 89,581 Income tax (benefit) expense (98 ) 3,346 Net income from discontinued operations $ 95,517 $ 105,108 The cash flows related to discontinued operations have not been segregated and are included in the Condensed Consolidated Statement of Cash Flows for the nine months ended September 30, 2018 . For the nine months ended September 30, 2018 , capital expenditures related to the CBR business were $1.6 million . Depreciation and amortization expense related to the CBR business for the same period was $8.4 million . Excluding the gain of $89.6 million recognized on the sale of the CBR business and the related transaction expenses of $14.1 million presented in the Condensed Consolidated Statement of Cash Flows, there were no other significant operating or investing non-cash items related to the CBR business for the nine months ended September 30, 2018 |
Revenue Recognition
Revenue Recognition | 9 Months Ended |
Sep. 30, 2019 | |
Revenue from Contract with Customer [Abstract] | |
Revenue Recognition | REVENUE RECOGNITION Our major sources of revenue during the reporting periods were product revenues from Makena, Feraheme, and Intrarosa. Product Revenue and Allowances and Accruals The following table provides information about disaggregated revenue by products for the three and nine months ended September 30, 2019 and 2018 (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Product sales, net Feraheme $ 44,205 $ 36,963 $ 126,294 $ 99,796 Makena 34,272 80,221 96,464 275,377 Intrarosa 5,607 4,925 14,898 10,331 Other 23 129 156 302 Total product sales, net $ 84,107 $ 122,238 $ 237,812 $ 385,806 Total gross product sales were offset by product sales allowances and accruals for the three and nine months ended September 30, 2019 and 2018 as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Gross product sales $ 254,073 $ 238,856 $ 704,976 $ 776,458 Provision for product sales allowances and accruals: Contractual adjustments 144,108 93,213 381,633 290,896 Governmental rebates 25,858 23,405 85,531 99,756 Total 169,966 116,618 467,164 390,652 Product sales, net $ 84,107 $ 122,238 $ 237,812 $ 385,806 The following table summarizes the product revenue allowance and accrual activity for the three and nine months ended September 30, 2019 (in thousands): Contractual Governmental Adjustments Rebates Total Balance at December 31, 2018 $ 57,199 $ 29,114 $ 86,313 Provisions related to current period sales 233,305 44,539 277,844 Adjustments related to prior period sales 4,200 15,134 19,334 Payments/returns relating to current period sales (176,392 ) (11,909 ) (188,301 ) Payments/returns relating to prior period sales (40,538 ) (36,362 ) (76,900 ) Balance at June 30, 2019 $ 77,774 $ 40,516 $ 118,290 Provisions related to current period sales 139,697 27,296 166,993 Adjustments related to prior period sales 4,475 (1,438 ) 3,037 Payments/returns relating to current period sales (117,780 ) (4,899 ) (122,679 ) Payments/returns relating to prior period sales (20,239 ) (2,611 ) (22,850 ) Balance at September 30, 2019 $ 83,927 $ 58,864 $ 142,791 We receive payments from customers based upon contractual billing schedules; accounts receivable are recorded when the right to consideration becomes unconditional. During the three and nine months ended September 30, 2019 , we recorded adjustments of $(1.4) million and $13.7 million , respectively, for Medicaid rebates received that related to prior period sales and $4.5 million and $8.7 million , respectively, for contractual adjustments related to prior period sales. We concluded that these adjustments represented changes in estimate during the three and nine months ended September 30, 2019 due to higher Medicaid and payer utilization and subsequent rebate obligations than anticipated based on our historical experience. Variable Consideration Under ASC 606, we are required to make estimates of the net sales price, including estimates of variable consideration (such as rebates, chargebacks, discounts, copay assistance and other deductions), and recognize the estimated amount as revenue, when we transfer control of the product to our customers. In addition, we estimated variable consideration related to our share of net distributable profits from our former authorized generic partner, Prasco LLC (“Prasco”). We estimate variable consideration for our product revenues using an “expected value” method. No amounts recognized as part of our product revenues were constrained as of September 30, 2019 . Collaboration Revenue During the first quarter of 2019, in conjunction with the Perosphere transaction, we assumed responsibility for a clinical trial collaboration agreement with a pharmaceutical company. This agreement provides for milestone payments to us, provided we meet certain clinical obligations in connection with our ciraparantag program. We also acquired $6.4 million of deferred revenue related to this agreement, which represents the fair value of upfront milestone payments received by Perosphere under this agreement prior to acquisition. During the quarter ended September 30, 2019 , we were informed by the pharmaceutical company of its intention to terminate the clinical trial collaboration agreement. Although we do not believe this company has grounds for termination, we are engaged in discussions with such partner to come to a mutually agreeable resolution. In accordance with ASC 808, we considered the nature and contractual terms of the arrangement and the nature of our business operations to determine the classification of payments under this agreement and concluded that the pharmaceutical company meets the definition of a customer. As a result, this agreement was accounted for under ASC 606. We determined that the promises to perform various research and development activities related to our ciraparantag program are not distinct because they are all necessary and highly interdependent with one another for the purpose of pursuing regulatory approval of ciraparantag. As such, these promises are combined into a single performance obligation, which is the submission for regulatory approval of ciraparantag in the U.S. and the European Union. In order to evaluate the appropriate transaction price, we considered that the remaining $34.8 million of potential milestone payments relate to activities which cannot progress until FDA clearance is received for a device needed to conduct the future clinical trials. As a result, these amounts were excluded from the transaction price and fully constrained based on the probability of achievement, which is outside of our control. In addition, as of September 30, 2019 , the transaction price is limited to the $6.3 million of deferred revenue acquired. We will reevaluate the transaction price, including all constrained amounts, at the end of each reporting period and as uncertain events are resolved or other changes in circumstances occur, and, if necessary, adjust our estimate of the transaction price. We will recognize revenue based on the transaction price determined at the end of each reporting period based on an input method in the form of research effort relative to expected research effort at the completion of the performance obligation. This is based on the relative costs of the research and development activities incurred and expected to be incurred in the future to satisfy the performance obligation, which is estimated to be completed over approximately two years . The estimated period of performance to satisfy the performance obligation and project cost is reviewed quarterly and adjusted, as needed, to reflect our current expectations regarding the costs and timing of the deliverable and will be updated in the event the agreement is terminated. These estimates are subject to a number of assumptions and actual results could differ materially from our assumptions in future periods. As of September 30, 2019 , deferred revenue related to the agreement amounted to $6.3 million , of which $1.1 million was included in current liabilities. No milestone payments were received during the nine months ended September 30, 2019 |
Marketable Securities
Marketable Securities | 9 Months Ended |
Sep. 30, 2019 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities | MARKETABLE SECURITIES As of September 30, 2019 and December 31, 2018 , our marketable securities were classified as available-for-sale in accordance with accounting standards which provide guidance related to accounting and classification of certain investments in marketable securities. Available-for-sale marketable securities are those securities which we view as available for use in current operations, if needed. We generally classify our available-for-sale marketable securities as short-term investments on our condensed consolidated balance sheets even though the stated maturity date may be one year or more beyond the current balance sheet date. We report realized gains and losses as a separate line within the condensed consolidated statements of operations on a specific identification basis. The following is a summary of our marketable securities as of September 30, 2019 and December 31, 2018 (in thousands): September 30, 2019 Gross Gross Estimated Amortized Unrealized Unrealized Fair Cost Gains Losses Value Short-term marketable securities:* Corporate debt securities $ 41,596 $ 130 $ (9 ) $ 41,717 Certificates of deposit 3,500 — — 3,500 U.S. treasury and government agency securities 6,247 — (3 ) 6,244 Commercial paper — — — — Total short-term marketable securities $ 51,343 $ 130 $ (12 ) $ 51,461 Long-term marketable securities:** Corporate debt securities $ 20,076 $ 207 $ — $ 20,283 Total long-term marketable securities 20,076 207 — 20,283 Total marketable securities $ 71,419 $ 337 $ (12 ) $ 71,744 * Represents marketable securities with a remaining maturity of less than one year. ** Represents marketable securities with a remaining maturity of one to three years classified as short-term on our condensed consolidated balance sheets. December 31, 2018 Gross Gross Estimated Amortized Unrealized Unrealized Fair Cost Gains Losses Value Short-term marketable securities:* Corporate debt securities $ 51,184 $ — $ (236 ) $ 50,948 U.S. treasury and government agency securities 7,647 — (34 ) 7,613 Commercial paper 3,995 — — 3,995 Certificates of deposit 12,000 — — 12,000 Total short-term marketable securities $ 74,826 $ — $ (270 ) $ 74,556 Long-term marketable securities:** Corporate debt securities $ 62,530 $ 52 $ (433 ) $ 62,149 U.S. treasury and government agency securities 2,742 — (32 ) 2,710 Certificates of deposit 1,500 — — 1,500 Total long-term marketable securities 66,772 52 (465 ) 66,359 Total marketable securities $ 141,598 $ 52 $ (735 ) $ 140,915 * Represents marketable securities with a remaining maturity of less than one year. ** Represents marketable securities with a remaining maturity of one to three years classified as short-term on our condensed consolidated balance sheets. Impairments and Unrealized Gains and Losses on Marketable Securities We did no t recognize any other-than-temporary impairment losses on our condensed consolidated statements of operations related to our marketable securities during the three and nine months ended September 30, 2019 and 2018 . We considered various factors, including the length of time that each security was in an unrealized loss position and our ability and intent to hold these securities until the recovery of their amortized cost basis occurs. As of September 30, 2019 , we had no material losses in an unrealized loss position for more than one year. Future events may occur, or additional information may become available, which may cause us to identify credit losses where we do not expect to receive cash flows sufficient to recover the entire amortized cost basis of a security and may necessitate the recording of future realized losses on securities in our portfolio. Significant losses in the estimated fair values of our marketable securities could have a material adverse effect on our earnings in future periods. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | FAIR VALUE MEASUREMENTS The following tables represent the fair value hierarchy as of September 30, 2019 and December 31, 2018 , for those assets and liabilities that we measure at fair value on a recurring basis (in thousands): Fair Value Measurements at September 30, 2019 Using: Quoted Prices in Significant Active Markets for Significant Other Unobservable Identical Assets Observable Inputs Inputs Total (Level 1) (Level 2) (Level 3) Assets: Cash equivalents $ 25,047 $ 25,047 $ — $ — Marketable securities: Corporate debt securities 62,000 — 62,000 — U.S. treasury and government agency securities 6,244 — 6,244 — Certificates of deposit 3,500 — 3,500 — Commercial paper — — — — Total marketable securities $ 71,744 $ — $ 71,744 $ — Total assets $ 96,791 $ 25,047 $ 71,744 $ — Liabilities: Contingent consideration - MuGard $ 293 $ — $ — $ 293 Total liabilities $ 293 $ — $ — $ 293 Fair Value Measurements at December 31, 2018 Using: Quoted Prices in Significant Active Markets for Significant Other Unobservable Identical Assets Observable Inputs Inputs Total (Level 1) (Level 2) (Level 3) Assets: Cash equivalents $ 71,568 $ 71,568 $ — $ — Corporate debt securities 113,097 — 113,097 — U.S. treasury and government agency securities 10,323 — 10,323 — Certificates of deposit 13,500 — 13,500 — Commercial paper 3,995 — 3,995 — Total assets $ 212,483 $ 71,568 $ 140,915 $ — Liabilities: Contingent consideration - MuGard 359 — — 359 Total liabilities $ 359 $ — $ — $ 359 Cash Equivalents Our cash equivalents are classified as Level 1 assets under the fair value hierarchy as these assets have been valued using quoted market prices in active markets and do not have any restrictions on redemption. As of September 30, 2019 and December 31, 2018 cash equivalents were primarily comprised of funds in money market accounts. Marketable Securities Our marketable securities are classified as Level 2 assets under the fair value hierarchy as the values of these assets are primarily determined from independent pricing services, which normally derive security prices from recently reported trades for identical or similar securities, making adjustments based upon other significant observable market transactions. At the end of each reporting period, we perform quantitative and qualitative analysis of prices received from third parties to determine whether prices are reasonable estimates of fair value. After completing our analysis, we did not adjust or override any fair value measurements provided by our pricing services as of September 30, 2019 . In addition, there were no transfers or reclassifications of any securities between Level 1 and Level 2 during the nine months ended September 30, 2019 . Contingent Consideration We recorded contingent consideration related to the November 2014 acquisition of Lumara Health Inc (“Lumara Health”) for our Makena product and related to our June 2013 license agreement for MuGard (the “MuGard License Agreement”) with Abeona Therapeutics, Inc., under which we acquired the U.S. commercial rights for the management of oral mucositis and stomatitis (the “MuGard Rights”). During the nine months ended September 30, 2018, we reduced the fair value of our Makena-related contingent consideration liability by approximately $49.2 million based primarily on actual Makena net sales to date and our expectations for future performance, which indicated that achievement of future milestones was not probable. This adjustment was based on our estimates, which were reliant on a number of external factors as well as the exercise of judgment. The fair value measurements of contingent consideration obligations and the related intangible assets arising from business combinations are classified as Level 3 estimates under the fair value hierarchy as these items have been valued using unobservable inputs. These inputs include: (a) the estimated amount and timing of projected cash flows; (b) the probability of the achievement of the factors on which the contingency is based; and (c) the risk-adjusted discount rate used to present value the probability-weighted cash flows. Significant increases or decreases in any of those inputs in isolation could result in a significantly lower or higher fair value measurement. The fair value of the contingent royalty payments payable by us to Abeona under the MuGard License Agreement was determined based on various market factors, including an analysis of estimated sales using a discount rate of approximately 13% . As of September 30, 2019 , we estimated that the undiscounted royalty amounts we could pay under the MuGard License Agreement, based on current projections, may range from approximately $0.3 million to $0.6 million over the remainder of the ten year period, which commenced on June 6, 2013, the acquisition date, which is our best estimate of the period over which we expect the majority of the asset’s cash flows to be derived. We believe the estimated fair value of contingent consideration obligations is based on reasonable assumptions; however, our actual results may vary significantly from the estimated results. Debt We estimate the fair value of our debt obligations by using quoted market prices obtained from third-party pricing services, which are classified as Level 2 inputs. As of September 30, 2019 , the estimated fair value of our 2022 Convertible Notes (as defined below) was $265.6 million , which differed from its carrying value. See Note R, “ Debt ” for additional information on our debt obligations. |
Inventories
Inventories | 9 Months Ended |
Sep. 30, 2019 | |
Inventory Disclosure [Abstract] | |
Inventories | INVENTORIES Our major classes of inventories were as follows as of September 30, 2019 and December 31, 2018 (in thousands): September 30, 2019 December 31, 2018 Raw materials $ 8,814 $ 9,388 Work in process 5,784 5,932 Finished goods 14,046 11,371 Total inventories $ 28,644 $ 26,691 |
Property and Equipment, Net
Property and Equipment, Net | 9 Months Ended |
Sep. 30, 2019 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | PROPERTY AND EQUIPMENT, NET Property and equipment, net consisted of the following as of September 30, 2019 and December 31, 2018 (in thousands): September 30, 2019 December 31, 2018 Computer equipment and software $ 1,672 $ 1,637 Furniture and fixtures 1,705 1,737 Leasehold improvements 4,859 2,938 Laboratory and production equipment 6,538 6,000 Construction in progress 125 420 14,899 12,732 Less: accumulated depreciation (6,987 ) (5,211 ) Property and equipment, net $ 7,912 $ 7,521 |
Goodwill and Intangible Assets,
Goodwill and Intangible Assets, Net | 9 Months Ended |
Sep. 30, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Goodwill and Intangible Assets, Net | GOODWILL AND INTANGIBLE ASSETS, NET Goodwill We test goodwill at the reporting unit level for impairment on an annual basis and between annual tests if events and circumstances indicate it is more likely than not that the fair value of a reporting unit is less than its carrying value. Events that could indicate impairment and trigger an interim impairment assessment include, but are not limited to, an adverse change in current economic and market conditions, including a significant prolonged decline in market capitalization, a significant adverse change in legal factors, unexpected adverse business conditions, and an adverse action or assessment by a regulator, such as an adverse FDA decision related to Makena in light of the discussions and votes at the recent Advisory Committee meeting. Our annual impairment test date is October 31. We have determined that we operate in a single operating segment and have a single reporting unit. During 2019, as a result of a number of business factors, including our market capitalization being below our carrying value, we performed qualitative interim impairment assessments of our goodwill balance as of each of the quarters ended March 31, 2019, June 30, 2019 and September 30, 2019 . We determined that it was not more likely than not that the fair value of our reporting unit was less than its carrying value and therefore, did not perform a further quantitative interim impairment test for any period. Our qualitative assessments were based on management’s estimates and assumptions, a number of which are dependent on external factors. To the extent actual results differ materially from these estimates and we experience negative developments in the areas discussed above in subsequent periods, an interim impairment assessment could be triggered, which could result in an impairment of goodwill. Intangible Assets Our developed technology intangible assets are related to certain of our commercial products. We assess intangible assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an intangible asset may not be recoverable. Events that could result in an impairment, or trigger an interim impairment assessment, include an adverse action or assessment by a regulator (such as an adverse FDA decision related to Makena, as discussed above), an adverse change in current economic and market conditions, or significant adverse changes in the long-range forecasts for a commercial product. When events or changes in circumstances indicate that the carrying amount of an intangible asset may not be recoverable, we calculate the excess of an intangible asset's carrying value over its undiscounted future cash flows. If the carrying value is not recoverable, an impairment loss is recognized based on the amount by which the carrying value exceeds the fair value. The inputs used in the fair value analysis fall within Level 3 of the fair value hierarchy due to the use of significant unobservable inputs to determine fair value. As of September 30, 2019 and December 31, 2018 , our intangible assets consisted of the following (in thousands): September 30, 2019 December 31, 2018 Accumulated Cumulative Accumulated Cumulative Cost Amortization Impairments Net Cost Amortization Impairments Net Finite-lived intangible assets: Makena base technology $ 797,100 $ 400,496 $ 396,604 $ — $ 797,100 $ 400,495 $ 319,246 $ 77,359 Makena auto-injector developed technology 79,100 13,716 — 65,384 79,100 6,952 — 72,148 Intrarosa developed technology 77,655 15,193 — 62,462 77,655 10,129 — 67,526 Vyleesi developed technology 60,000 269 — 59,731 — — — — Total intangible assets $ 1,013,855 $ 429,674 $ 396,604 $ 187,577 $ 953,855 $ 417,576 $ 319,246 $ 217,033 During the second quarter of 2019 , Vyleesi received FDA approval, which triggered a $60.0 million milestone payment, which was capitalized as developed technology. Late in the second quarter of 2019, we were notified that an additional manufacturing site for the Makena intramuscular (“IM”) products, which relates to the Makena base technology intangible asset, received FDA approval. However, the approval was received later than expected and the extended period of the stock-out caused our authorized generic partner to lose additional customers and market share, resulting in no shipments of IM to our authorized generic partner during that quarter. As a result of this loss of market share, we deemed it probable as of the end of the second quarter of 2019 that we would terminate the Distribution and Supply Agreement with our authorized generic partner. We do not expect to generate any future revenues from shipments of the IM products. Accordingly, we eliminated the Makena IM products from our long-term revenue forecast during the second quarter of 2019. These business factors were considered indicators of potential impairment for the Makena base technology intangible asset during the second quarter of 2019. We determined that the fair value of the Makena base technology intangible asset was zero at June 30, 2019, and as a result, we recorded an impairment charge for the full remaining value of the asset of $77.4 million , which was recorded within a separate operating expense line item on our condensed consolidated statements of operations. The Distribution and Supply Agreement with our authorized generic partner was terminated in August 2019. As of September 30, 2019 , the weighted average remaining amortization period for our finite-lived intangible assets was approximately 8.6 years . Total amortization expense for the nine months ended September 30, 2019 and 2018 was $12.1 million and $144.7 million , respectively. Amortization expense is recorded in cost of product sales on our condensed consolidated statements of operations. We expect amortization expense related to our finite-lived intangible assets to be as follows (in thousands): Estimated Amortization Period Expense Remainder of Year Ending December 31, 2019 $ 5,557 Year Ending December 31, 2020 22,229 Year Ending December 31, 2021 22,229 Year Ending December 31, 2022 22,229 Year Ending December 31, 2023 22,229 Thereafter 93,104 Total $ 187,577 |
Current Liabilities
Current Liabilities | 9 Months Ended |
Sep. 30, 2019 | |
Payables and Accruals [Abstract] | |
Current Liabilities | CURRENT LIABILITIES Accrued expenses consisted of the following as of September 30, 2019 and December 31, 2018 (in thousands): September 30, 2019 December 31, 2018 Commercial rebates, fees and returns $ 127,138 $ 80,520 Professional, license, and other fees and expenses 18,964 23,242 Salaries, bonuses, and other compensation 17,498 22,482 Research and development expense 4,020 2,226 Interest expense 3,467 1,067 Restructuring expense 1,198 — Total accrued expenses $ 172,285 $ 129,537 |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | INCOME TAXES The following table summarizes our effective tax rate and income tax expense (benefit) from continuing operations for the three and nine months ended September 30, 2019 and 2018 (in thousands except for percentages): Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Effective tax rate (1 )% 4 % — % (40 )% Income tax expense (benefit) $ 232 $ (2,352 ) $ (26 ) $ 42,204 For the three and nine months ended September 30, 2019 , we recognized an income tax expense of $0.2 million and an immaterial income tax benefit, respectively, representing an effective tax rate of (1)% and 0% respectively. The difference between the statutory federal tax rate of 21% and the effective tax rate for the three and nine months ended September 30, 2019 , was primarily attributable to the valuation allowance established against our current period losses generated and the non-deductible IPR&D expense related to the Perosphere acquisition. We have established a valuation allowance on our deferred tax assets other than refundable alternative minimum tax (“AMT”) credits to the extent that our existing taxable temporary differences would not be available as a source of income to realize the benefits of those deferred tax assets. The income tax expense for the three months ended September 30, 2019 primarily related to state taxes. The income tax benefit for the nine months ended September 30, 2019 primarily related to the offset of the recognition of the income tax expense recorded in other comprehensive loss associated with the increase in the value of available-for-sale securities that we carried at fair market value during the period, partially offset by state income taxes. For the three and nine months ended September 30, 2018 , we recognized an income tax benefit of $2.4 million and an income tax expense of $42.2 million , respectively, representing an effective tax rate of 4% and (40)% , respectively. The difference between the statutory federal tax rate of 21% and the effective tax rates for the three and nine months ended September 30, 2018 was primarily attributable to the establishment of a valuation allowance on net deferred tax assets other than refundable AMT credits, the impact of non-deductible stock compensation and other non-deductible expenses, partially offset by a benefit from contingent consideration, state income taxes and orphan drug credits. The primary driver of the increase in tax expense for the three months ended September 30, 2019 as compared to the three months ended September 30, 2018 was state income taxes. The primary driver of the decrease in tax expense for the nine months ended September 30, 2019 as compared to the nine months ended September 30, 2018 was the valuation allowance established. |
Accumulated Other Comprehensive
Accumulated Other Comprehensive Loss | 9 Months Ended |
Sep. 30, 2019 | |
Equity [Abstract] | |
Accumulated Other Comprehensive Loss | ACCUMULATED OTHER COMPREHENSIVE LOSS The following table summarizes the changes in the accumulated balances of other comprehensive loss during the three and nine months ended September 30, 2019 and 2018 (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Beginning balance $ (3,032 ) $ (4,295 ) $ (3,985 ) $ (3,908 ) Holding (losses) gains associated with marketable securities arising during period, net of tax (167 ) 134 786 (253 ) Ending balance $ (3,199 ) $ (4,161 ) $ (3,199 ) $ (4,161 ) |
Earnings Per Share
Earnings Per Share | 9 Months Ended |
Sep. 30, 2019 | |
Earnings Per Share [Abstract] | |
Earnings Per Share | EARNINGS PER SHARE The components of basic and diluted earnings per share for the three and nine months ended September 30, 2019 and 2018 were as follows (in thousands, except per share data): Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Net loss from continuing operations $ (23,617 ) $ (64,678 ) $ (266,528 ) $ (148,592 ) Net income from discontinued operations — 95,517 — 105,108 Net (loss) income $ (23,617 ) $ 30,839 $ (266,528 ) $ (43,484 ) Weighted average common shares outstanding 33,906 34,492 34,058 34,339 Basic and diluted net (loss) income per share: Loss from continuing operations $ (0.70 ) $ (1.88 ) $ (7.83 ) $ (4.33 ) Income from discontinued operations — 2.77 — 3.06 Basic and diluted net (loss) income per share $ (0.70 ) $ 0.89 $ (7.83 ) $ (1.27 ) The following table sets forth the potential common shares issuable upon the exercise of outstanding options, the vesting of restricted stock units (“RSUs”), and the conversion of the Convertible Notes, which were excluded from our computation of diluted net loss per share because their inclusion would have been anti-dilutive (in thousands): Nine Months Ended September 30, 2019 2018 Options to purchase shares of common stock 3,988 3,700 Shares of common stock issuable upon the vesting of RSUs 1,645 1,135 Warrants — 1,008 2022 Convertible Notes 11,695 11,695 2019 Convertible Notes — 790 Total 17,328 18,328 In connection with the issuance of the 2019 Convertible Notes in February 2014, we entered into convertible bond hedges. The convertible bond hedges are not included for purposes of calculating the number of diluted shares outstanding, as their effect would be anti-dilutive. The convertible bond hedges were terminated in February 2019 in connection with the maturity of the 2019 Convertible Notes. |
Equity-Based Compensation
Equity-Based Compensation | 9 Months Ended |
Sep. 30, 2019 | |
Share-based Payment Arrangement [Abstract] | |
Equity-Based Compensation | EQUITY‑BASED COMPENSATION We currently maintain three equity compensation plans; our 2019 Equity Incentive Plan (the “2019 Plan”), which was approved by our stockholders at our 2019 annual meeting and replaced our Fourth Amended and Restated 2007 Equity Incentive Plan (the “2007 Plan”), the Lumara Health Inc. Amended and Restated 2013 Incentive Compensation Plan (the “Lumara Health 2013 Plan”) and our 2015 Employee Stock Purchase Plan (“2015 ESPP”). All outstanding stock options granted under each of our equity compensation plans other than our 2015 ESPP have an exercise price equal to the closing price of a share of our common stock on the grant date. Stock Options The following table summarizes stock option activity for the nine months ended September 30, 2019 : 2019 Equity 2007 Equity 2013 Lumara Inducement Plan Plan Equity Plan Grants Total Outstanding at December 31, 2018 — 2,781,786 124,450 810,343 3,716,579 Granted 344,208 465,009 34,700 80,366 924,283 Exercised — (2,025 ) — — (2,025 ) Expired or terminated — (585,312 ) (26,275 ) (131,250 ) (742,837 ) Outstanding at September 30, 2019 344,208 2,659,458 132,875 759,459 3,896,000 Restricted Stock Units The following table summarizes RSU activity for the nine months ended September 30, 2019 : 2019 Equity 2007 Equity 2013 Lumara Inducement Plan Plan Equity Plan Grants Total Outstanding at December 31, 2018 — 1,041,141 2,101 85,293 1,128,535 Granted 123,228 1,023,847 1,100 29,385 1,177,560 Vested — (354,563 ) (1,034 ) (44,909 ) (400,506 ) Expired or terminated (1,800 ) (250,968 ) — (7,500 ) (260,268 ) Outstanding at September 30, 2019 121,428 1,459,457 2,167 62,269 1,645,321 In February 2019 , we granted RSUs under our 2007 Plan to certain members of our senior management covering a maximum of 365,591 shares of common stock. These performance-based RSUs will vest, if at all, on February 24, 2022, based on our total shareholder return performance measured against the median total shareholder return of a defined group of companies over a three-year period. As of September 30, 2019 , the maximum shares of common stock that may be issued under these awards is 347,591 . The maximum aggregate total fair value of these RSUs is $4.5 million , which is being recognized as expense over a period of three years from the date of grant, net of any actual forfeitures. Equity-Based Compensation Expense Equity-based compensation expense for the three and nine months ended September 30, 2019 and 2018 consisted of the following (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Cost of product sales $ 225 $ 281 $ 626 $ 588 Research and development 691 568 2,051 1,896 Selling, general and administrative 4,058 4,202 11,039 12,149 Total equity-based compensation expense 4,974 5,051 13,716 14,633 Income tax effect — — — — After-tax effect of equity-based compensation expense $ 4,974 $ 5,051 $ 13,716 $ 14,633 In addition to the equity-based compensation expense presented in the table above, we incurred $0.7 million of equity-based compensation expense related to the restructuring activities during the first quarter of 2019, which is classified within restructuring expense on our condensed consolidated statement of operations for the nine months ended September 30, 2019 . |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2019 | |
Equity [Abstract] | |
Stockholders' Equity | STOCKHOLDERS’ EQUITY As of January 1, 2019, we had $20.5 million available under our previously approved share repurchase program to repurchase up to $60.0 million in shares of our common stock. In March 2019, our Board authorized additional repurchases of shares in an amount up to $20.0 million under this program. During the nine months ended September 30, 2019 , we repurchased and retired 1,074,800 shares of common stock for $13.7 million . As of September 30, 2019 , $26.8 million |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | COMMITMENTS AND CONTINGENCIES Commitments Our long-term contractual obligations include commitments and estimated purchase obligations entered into in the normal course of business. These include commitments related to our facility, vehicle and equipment leases, purchases of inventory, debt obligations, and other purchase obligations. Operating Lease Obligations As of January 1, 2019, we had operating leases for our corporate headquarters and vehicles utilized by sales employees. Accordingly, we recorded operating lease liabilities of $8.5 million and related ROU assets of $7.6 million as of January 1, 2019 in connection with our adoption of ASC 842. During the first quarter of 2019, we acquired a lease for office space in conjunction with the Perosphere transaction, entered into a new lease for office equipment and terminated certain vehicle leases in conjunction with our restructuring activities. There was no material gain or loss recognized on the early termination of the vehicle leases. As of September 30, 2019 , we had operating lease liabilities of $7.3 million and related ROU assets of $6.6 million . As of September 30, 2019 , our leases have remaining terms of one to four years . The weighted average remaining lease term and discount rate for our operating leases was 2.1 years and 4.63% at September 30, 2019 , respectively. Lease costs for our operating leases were $1.4 million and $3.9 million for the three and nine months ended September 30, 2019 , respectively. Operating cash outflows for operating leases were $4.2 million for the nine months ended September 30, 2019 and ROU assets obtained in exchange for lease obligations were $1.0 million during the nine months ended September 30, 2019 . Future minimum payments under our non-cancelable operating leases as of September 30, 2019 are as follows (in thousands): Period Future Minimum Lease Payments Remainder of Year Ending December 31, 2019 $ 1,073 Year Ending December 31, 2020 4,081 Year Ending December 31, 2021 1,881 Year Ending December 31, 2022 583 Year Ending December 31, 2023 53 Thereafter — Total $ 7,671 Less: Interest 333 Operating lease liability $ 7,338 Under the prior lease guidance, future minimum payments under our non-cancellable leases as of December 31, 2018 were as follows (in thousands): Period Future Minimum Lease Payments Year Ending December 31, 2019 $ 5,119 Year Ending December 31, 2020 4,075 Year Ending December 31, 2021 1,034 Year Ending December 31, 2022 — Year Ending December 31, 2023 — Total $ 10,228 Purchase Obligations Purchase obligations primarily represent minimum purchase commitments for inventory. As of September 30, 2019 , our minimum purchase commitments totaled $50.5 million . Contingent Consideration Related to Business Combinations In connection with our acquisition of Lumara Health in November 2014, we agreed to pay up to $350.0 million based on the achievement of certain sales milestones, of which $150.0 million has been paid to date. During the second quarter of 2018, we reversed the accrual for a $50.0 million milestone payment based on actual Makena net sales to date and our expectations for future performance, which indicated that achievement of the future milestone was not probable. As we update our analysis in future periods, actual results may vary significantly from the estimated results, which are reliant on a number of external factors as well as the exercise of judgment. Contingent Regulatory and Commercial Milestone Payments In January 2019, we acquired Perosphere, a privately-held biopharmaceutical company focused on developing ciraparantag, a small molecule anticoagulant reversal agent. Under and subject to the terms and conditions set forth in the Perosphere Agreement (described below), we are obligated to pay future contingent consideration of up to an aggregate of $365.0 million (the “Milestone Payments”), including (a) up to an aggregate of $140.0 million that becomes payable upon the achievement of specified regulatory milestones for ciraparantag (the “Regulatory Milestone Payments”), including a $40.0 million milestone payment upon approval of ciraparantag by the European Medicines Agency and (b) up to an aggregate of $225.0 million that becomes payable conditioned upon the achievement of specified sales milestones (the “Sales Milestone Payments”). If the final label approved for ciraparantag in the U.S. includes a boxed warning, the Regulatory Milestone Payments shall no longer be payable, and any previously paid Regulatory Milestone Payments shall be credited against 50% of any future Milestone Payments that otherwise becomes payable. The first Sales Milestone Payment of $20.0 million will be payable upon annual net sales of ciraparantag of at least $100.0 million . For more information on the Perosphere acquisition, see Note Q, “ Acquisitions, Collaboration, License and Other Strategic Agreements.” In September 2018, we exercised our option to acquire the global rights to AMAG-423 pursuant to an option agreement entered into in July 2015 with Velo Bio, LLC, a privately-held life-sciences company (“Velo”), the terms of which were amended at the time of exercise. In connection with the exercise of the option and consummation of the acquisition, we are responsible for completing the Phase 2b/3a clinical study that Velo initiated in the second quarter of 2017 and will incur all of the clinical, regulatory and other costs required to pursue FDA approval. We are obligated to pay Velo a $30.0 million milestone payment upon FDA approval of AMAG-423. In addition, we are obligated to pay sales milestone payments of up to $240.0 million in the aggregate, triggered at various annual net sales thresholds between $300.0 million and $900.0 million and low-single digit royalties based on net sales. Further, we have assumed additional obligations under a previous agreement entered into by Velo with a third-party, including a $5.0 million milestone payment upon regulatory approval and $10.0 million following the first commercial sale of AMAG-423, payable in quarterly installments as a percentage of quarterly gross commercial sales until the obligation is met. We are also obligated to pay the third-party low-single digit royalties based on net sales. In connection with a license agreement we entered into with Endoceutics, Inc. (“Endoceutics”) in February 2017 (the “Endoceutics License Agreement”), we are required to pay Endoceutics certain sales milestone payments, including a first sales milestone payment of $15.0 million , which would be triggered when Intrarosa annual net U.S. sales exceed $150.0 million , and a second milestone payment of $30.0 million , which would be triggered when annual net U.S. sales of Intrarosa exceed $300.0 million . If annual net U.S. sales of Intrarosa exceed $500.0 million , there are additional sales milestone payments totaling up to $850.0 million , which would be triggered at various sales thresholds. We are also obligated to pay tiered royalties equal to a percentage of net U.S. sales of Intrarosa ranging from mid-teens for calendar year net sales up to $150.0 million to mid twenty percent for any calendar year net sales that exceed $1.0 billion for the commercial life of Intrarosa, with deductions (a) after the later of (i) the expiration date of the last to expire of a licensed patent containing a valid patent claim or (ii) ten years after the first commercial sale of Intrarosa for the treatment of vulvar and vaginal atrophy (“VVA”) or female sexual dysfunction (“FSD”) in the U.S. (as applicable), (b) for generic competition and (c) for third party payments, subject to an aggregate cap on such deductions of royalties otherwise payable to Endoceutics. For more information on the Endoceutics License Agreement, see Note Q, “ Acquisitions, Collaboration, License and Other Strategic Agreements. ” In connection with a license agreement we entered into with Palatin Technologies, Inc. (“Palatin”) in January 2017 (the “Palatin License Agreement”), we were required to pay Palatin $60.0 million upon FDA approval of Vyleesi, which was paid in July 2019. We are also required to pay up to $300.0 million of aggregate sales milestone payments upon the achievement of certain annual net sales milestones over the course of the license. The first sales milestone payment of $25.0 million will be triggered when Vyleesi annual net sales exceed $250.0 million . We are also obligated to pay tiered royalties on annual net sales in North America of the Vyleesi Products, on a product-by-product basis, in the Palatin Territory ranging from the high-single digits to the low double-digits. The royalties will expire on a product-by-product and country-by-country basis upon the latest to occur of (a) the earliest date on which there are no valid claims of Palatin patent rights covering such Vyleesi Product in such country, (b) the expiration of the regulatory exclusivity period for such Vyleesi Product in such country and (c) 10 years following the first commercial sale of such Vyleesi Product in such country. These royalties are subject to reduction in the event that: (x) we must license additional third-party intellectual property in order to develop, manufacture or commercialize a Vyleesi Product or (y) generic competition occurs with respect to a Vyleesi Product in a given country, subject to an aggregate cap on such deductions of royalties otherwise payable to Palatin. After the expiration of the applicable royalties for any Vyleesi Product in a given country, the license for such Vyleesi Product in such country would become a fully paid-up, royalty-free, perpetual and irrevocable license. For more information on the Palatin License Agreement, see Note Q, “ Acquisitions, Collaboration, License and Other Strategic Agreements. ” In connection with a development and license agreement (the “Antares License Agreement”) with Antares Pharma, Inc. (“Antares”), we are required to pay royalties to Antares on net sales of the Makena auto-injector commencing on the launch of the Makena auto-injector in a particular country until the Makena auto-injector is no longer sold or offered for sale in such country or the Antares License Agreement is terminated (the “Antares Royalty Term”). The royalty rates range from high single digit to low double digits and are tiered based on levels of net sales of the Makena auto-injector and decrease after the expiration of licensed patents or where there are generic equivalents to the Makena auto-injector being sold in a particular country. Antares is also entitled to sales-based milestone payments upon the achievement of certain annual net sales. For more information on the Antares License Agreement, see Note Q, “ Acquisitions, Collaboration, License and Other Strategic Agreements. ” Contingencies Legal Proceedings We accrue a liability for legal contingencies when we believe that it is both probable that a liability has been incurred and that we can reasonably estimate the amount of the loss. We review these accruals and adjust them to reflect ongoing negotiations, settlements, rulings, advice of legal counsel and other relevant information. To the extent new information is obtained and our views on the probable outcomes of claims, suits, assessments, investigations or legal proceedings change, changes in our accrued liabilities would be recorded in the period in which such determination is made. For certain matters referenced below, the liability is not probable or the amount cannot be reasonably estimated and, therefore, accruals have not been made. In addition, in accordance with the relevant authoritative guidance, for any matters in which the likelihood of material loss is at least reasonably possible, we will provide disclosure of the possible loss or range of loss. If a reasonable estimate cannot be made, however, we will provide disclosure to that effect. We expense legal costs as they are incurred. On August 29, 2019, Lunar Representative, LLC (“Plaintiff”), on behalf of the former equityholders of Lumara Health Inc. (“Lumara”), filed a complaint against us in the Delaware Court of Chancery, captioned Lunar Representative, LLC v. AMAG Pharmaceuticals, Inc. (No. 2019-0688-JTL). Plaintiff alleges that we did not exercise commercially reasonable efforts to market and sell the drug product Makena, and failed to achieve sales milestones for Makena, in breach of certain provisions of the September 28, 2014 Agreement and Plan of Merger between, among other parties, us and Lumara. On September 25, 2019, we filed a motion to dismiss the complaint. Plaintiff is seeking damages of $50.0 million , together with pre- and post-judgment interest, as well as attorneys’ fees and costs. At this time, based on available information, we are unable to reasonably assess the ultimate outcome of this case or determine an estimate, or a range of estimates, of potential losses. We believe this lawsuit is without merit and intend to vigorously defend against the allegations. On or about April 6, 2016, we received Notice of a Lawsuit and Request to Waive Service of a Summons in a case entitled Plumbers’ Local Union No. 690 Health Plan v. Actavis Group et. al. (“Plumbers’ Union”), which was filed in the Court of Common Pleas of Philadelphia County, First Judicial District of Pennsylvania and, after removal to federal court, is now pending in the United States District Court for the Eastern District of Pennsylvania (Civ. Action No. 16-65-AB). Thereafter, we were also made aware of a related complaint entitled Delaware Valley Health Care Coalition v. Actavis Group et. al. (“Delaware Valley”), which was filed with the Court of Common Pleas of Philadelphia County, First Judicial District of Pennsylvania District Court of Pennsylvania (Case ID: 160200806). The complaints name K-V Pharmaceutical Company (“KV”) (Lumara Health’s predecessor company), certain of its successor entities, subsidiaries and affiliate entities (the “Subsidiaries”), along with a number of other pharmaceutical companies. We acquired Lumara Health in November 2014, a year after KV emerged from bankruptcy protection, at which time it, along with its then existing subsidiaries, became our wholly-owned subsidiary. We have not been served with process or waived service of summons in either case. The actions are being brought alleging unfair and deceptive trade practices with regard to certain pricing practices that allegedly resulted in certain payers overpaying for certain of KV’s generic products. On July 21, 2016, the Plaintiff in the Plumbers’ Union case dismissed KV with prejudice to refiling and on October 6, 2016, all claims against the Subsidiaries were dismissed without prejudice. We are in discussions with Plaintiff’s counsel to similarly dismiss all claims in the Delaware Valley case. Because we have not been served with process in the Delaware Valley case, we are currently unable to predict the outcome or reasonably estimate the range of potential loss associated with this matter, if any. On July 20, 2015, the Federal Trade Commission (the “FTC”) notified us that it was conducting an investigation into whether Lumara Health or its predecessor engaged in unfair methods of competition with respect to Makena or any hydroxyprogesterone caproate product. As previously disclosed, we provided the FTC with a response in August 2015. We believe we have fully cooperated with the FTC and we have had no further interactions with the FTC on this matter since our response in August 2015. For further information on this matter, see Note P, “ Commitments and Contingencies ” to our Annual Report. We may periodically become subject to other legal proceedings and claims arising in connection with ongoing business activities, including claims or disputes related to patents that have been issued or that are pending in the field of research on which we are focused. Other than the above actions, we are not aware of any material claims against us as of September 30, 2019 . |
Acquisitions, Collaboration, Li
Acquisitions, Collaboration, License and Other Strategic Agreements | 9 Months Ended |
Sep. 30, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Acquisitions, Collaboration, License and Other Strategic Agreements | ACQUISITIONS, COLLABORATION, LICENSE AND OTHER STRATEGIC AGREEMENTS Our commercial strategy includes expanding our portfolio through the in-license or acquisition of additional pharmaceutical products or companies, including revenue-generating commercial products and development assets as well as forming alliances with other companies to facilitate the sale and distribution of our products. During the nine months ended September 30, 2019 , we were a party to the following agreements: Perosphere On January 16, 2019, we acquired Perosphere pursuant to the Agreement and Plan of Merger (the “Perosphere Agreement”), dated as of December 12, 2018 between AMAG and Perosphere. Pursuant to the Perosphere Agreement, in January 2019, we paid approximately $50.0 million (the “Upfront Merger Consideration”), subject to adjustments for working capital, cash, transaction expenses and specified indebtedness. Of the Upfront Merger Consideration, approximately $40.0 million was funded from our available cash and approximately $10.0 million was deemed paid in connection with the cancellation of a convertible note in the principal amount of $10.0 million issued to us by Perosphere in October 2018. The purchase price was subject to customary post-closing adjustments under the Perosphere Agreement. In addition to the Upfront Merger Consideration, we used available cash to repay $12.0 million of Perosphere’s term loan indebtedness and approximately $6.2 million of Perosphere’s other liabilities. We are also required to pay regulatory and sales milestone payments to Perosphere as described in more detail above in Note P, “ Commitments and Contingencies. ” Further, we are a party to a clinical trial collaboration agreement with a pharmaceutical company, which we acquired through the Perosphere transaction, which provided for partial funding of the Phase 3 program for ciraparantag if certain clinical milestones are met. In August 2019, the pharmaceutical company informed us that it intends to terminate the agreement. Although we do not believe this company has grounds for termination, we are engaged in discussions with such partner to come to a mutually agreeable resolution. Substantially all of the fair value of the assets acquired in conjunction with the Perosphere transaction was concentrated in the IPR&D asset. As a result, we accounted for this transaction as an asset acquisition under ASU No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business (“ASU 2017-01”). The acquired IPR&D was charged to expense at acquisition, as it relates to a development stage compound with no alternative future use. A summary of the assets and liabilities acquired in exchange for cash consideration of $60.8 million and $10.0 million that was deemed paid in connection with the cancellation of the convertible note, described above, is presented in the following table (in millions): Assets: Cash $ 2.6 Operating lease right-of-use asset 0.8 Property and equipment 1.4 IPR&D 74.9 $ 79.7 Liabilities: Accrued severance liabilities $ (1.7 ) Deferred revenue (6.4 ) Operating lease liability (0.8 ) $ (8.9 ) Excluded from the table above are contingent payments associated with achievement of potential regulatory and sales milestones as described in Note P “ Commitments and Contingencies, ” which were not deemed probable at the date of acquisition. The fair values of certain of the assets and liabilities acquired are classified as Level 3 estimates under the fair value hierarchy as they have been valued using unobservable inputs. These inputs include: (a) the estimated amount and timing of projected cash flows; (b) the probability of the achievement of key development and regulatory objectives; and (c) the risk-adjusted discount rate used to present value the probability-weighted cash flows. The fair values of the assets and liabilities acquired were initially valued and recorded based on various market factors, including an analysis of estimated sales using a discount rate of approximately 34% . Velo In September 2018, we exercised our option to acquire the global rights to the AMAG-423 program, which we accounted for as an asset acquisition under ASU No. 2017-01 . For more information on the AMAG-423 acquisition, see Note P, “ Commitments and Contingencies. ” Prasco In December 2017, we entered into a Distribution and Supply Agreement (the “Prasco Agreement”) with Prasco, LLC (“Prasco”), under which Prasco was granted an exclusive, non-sublicensable, nontransferable license to purchase, distribute and sell a generic version of the Makena IM product in the U.S. (the “Makena authorized generic”). In July 2018, Prasco launched the Makena authorized generic of both the single-dose and multi-dose IM injections and in August 2019, we and Prasco terminated the Prasco Agreement based on our determination that it was not commercially viable to continue the relationship and, therefore, we do not expect to ship any further authorized generic product to Prasco. Under the Prasco Agreement, we were responsible for the manufacture and supply of the Makena authorized generic to be sold to Prasco at a predetermined supply price. Prasco was also required to pay us a certain percentage of the net distributable profits from the sale of the Makena authorized generic. We accounted for revenue recognized under the Prasco Agreement in accordance with ASC 606. Pursuant to the terms of the Prasco Agreement, in certain circumstances we have reimbursed and may be required to reimburse Prasco for additional penalties incurred by Prasco as a result of our failure to supply a certain percentage of product ordered by Prasco in a prespecified timeframe. During the nine months ended September 30, 2019 , we incurred $3.5 million of failure to supply penalties, the majority of which were incurred in the first quarter of 2019. Antares We are party to the Antares License Agreement, which grants us an exclusive, worldwide, royalty-bearing license, with the right to sublicense, to certain intellectual property rights, including know-how, patents and trademarks, to develop, use, sell, offer for sale and import and export the Makena auto-injector. Under the terms of the Antares License Agreement, as amended in March 2018, we are responsible for the clinical development and preparation, submission and maintenance of all regulatory applications in each country where we desire to market and sell the Makena auto-injector, including the U.S. We are also required to pay royalties to Antares as described in more detail above in Note P, “ Commitments and Contingencies. ” The Antares License Agreement terminates at the end of the Antares Royalty Term, but is subject to early termination by us for convenience and by either party upon an uncured breach by or bankruptcy of the other party. In March 2018, the Antares License Agreement was amended to, among other things, transfer the agreement to AMAG from our subsidiary, amend certain confidentiality provisions, and to provide for co-termination with the Antares Manufacturing Agreement (described below). We are also party to a Manufacturing Agreement with Antares (the “Antares Manufacturing Agreement”) that sets forth the terms and conditions pursuant to which Antares agreed to sell to us on an exclusive basis, and we agreed to purchase, the fully packaged Makena auto-injector for commercial distribution. Antares remains responsible for the manufacture and supply of the device components and assembly of the Makena auto-injector. We are responsible for the supply of the drug to be used in the assembly of the finished auto-injector product. The Antares Manufacturing Agreement terminates at the expiration or earlier termination of the Antares License Agreement, but is subject to early termination by us for certain supply failure situations, and by either party upon an uncured breach by or bankruptcy of the other party or our permanent cessation of commercialization of the Makena auto-injector for efficacy or safety reasons. Endoceutics In February 2017, we entered into the Endoceutics License Agreement. Pursuant to the Endoceutics License Agreement, Endoceutics granted us the right to develop and commercialize pharmaceutical products containing dehydroepiandrosterone (“DHEA”), including Intrarosa, at dosage strengths of 13 mg or less per dose and formulated for intravaginal delivery, excluding any combinations with other active pharmaceutical ingredients, in the U.S. for the treatment of VVA and FSD. We accounted for the Endoceutics License Agreement as an asset acquisition under ASU 2017-01. Upon the closing of the Endoceutics License Agreement, we made an upfront payment of $50.0 million and issued 600,000 shares of unregistered common stock to Endoceutics, which had a value of $13.5 million , as measured on April 3, 2017, the date of closing. In addition, we paid Endoceutics $10.0 million in 2017 upon the delivery by Endoceutics of Intrarosa launch quantities and $10.0 million in 2018 following the first anniversary of the closing. In 2017, we recorded a total of $83.5 million of consideration, of which $77.7 million was allocated to the Intrarosa developed technology intangible asset and $5.8 million was recorded as IPR&D expense based on their relative fair values. In addition, we are required to pay royalties and sales milestone payments to Endoceutics as described in more detail above in Note P, “ Commitments and Contingencies. ” In the third quarter of 2017, Endoceutics initiated a clinical study with Intrarosa for the treatment of HSDD in post-menopausal women. Upon review of the full data set, Endoceutics recently determined not to pursue an additional clinical trial to support an HSDD indication. We had agreed to share the direct costs related to such studies based upon a negotiated allocation with us funding up to $20.0 million , of which we have paid approximately $6.0 million , which was recorded as research and development expense as incurred. We have the exclusive right to commercialize Intrarosa for the treatment of VVA and FSD in the U.S., subject to the terms of the Endoceutics License Agreement. We have agreed to use commercially reasonable efforts to market, promote and otherwise commercialize Intrarosa for the treatment of VVA and, if approved, FSD in the U.S. Endoceutics has the right to directly conduct additional commercialization activities for Intrarosa for the treatment of VVA and FSD in the U.S. and has the right to conduct activities related generally to the field of intracrinology, in each case, subject to our review and approval and our right to withhold approval in certain instances. Each party’s commercialization activities and budget are described in a commercialization plan, which is updated annually. In April 2017, we entered into an exclusive commercial supply agreement with Endoceutics pursuant to which Endoceutics, itself or through affiliates or contract manufacturers, agreed to manufacture and supply Intrarosa to us (the “Endoceutics Supply Agreement”) and is our exclusive supplier of Intrarosa in the U.S., subject to certain rights for us to manufacture and supply Intrarosa in the event of a cessation notice or supply failure (as such terms are defined in the Endoceutics Supply Agreement). Under the Endoceutics Supply Agreement, Endoceutics has agreed to maintain at all times a second source supplier for the manufacture of DHEA and the drug product. The Endoceutics Supply Agreement will generally remain in effect until the termination of the Endoceutics License Agreement. The Endoceutics License Agreement expires on the date of expiration of all royalty obligations due thereunder unless earlier terminated in accordance with the Endoceutics License Agreement. Palatin In January 2017, we entered into the Palatin License Agreement under which we acquired (a) an exclusive license in all countries of North America (the “Palatin Territory”), with the right to grant sub-licenses, to research, develop and commercialize the Vyleesi products, a product for the treatment of acquired, generalized HSDD in pre-menopausal women, (b) a worldwide non-exclusive license, with the right to grant sub-licenses, to manufacture the Vyleesi Products, and (c) a non-exclusive license in all countries outside the Palatin Territory, with the right to grant sub-licenses, to research and develop (but not commercialize) the Vyleesi Products. The transaction closed in February 2017 and was accounted for as an asset acquisition under ASU 2017-01. Under the terms of the Palatin License Agreement, in February 2017 we paid Palatin $60.0 million as a one-time upfront payment and subject to agreed-upon deductions reimbursed Palatin approximately $25.0 million for reasonable, documented, out-of-pocket expenses incurred by Palatin in connection with the development and regulatory activities necessary to submit an NDA in the U.S. for Vyleesi for the treatment of HSDD in pre-menopausal women. During 2017, we fulfilled these payment obligations to Palatin. The $60.0 million upfront payment made in February 2017 to Palatin was recorded as IPR&D expense as the product candidate had not received regulatory approval. In June 2018, our NDA submission to the FDA for Vyleesi was accepted, which triggered a $20.0 million milestone payment, which we paid in the second quarter of 2018 and recorded as an IPR&D expense in the first quarter of 2018 when acceptance was deemed probable. In June 2019, the FDA approval of Vyleesi triggered a $60.0 million milestone payment to Palatin, which we paid in July 2019 and recorded as a developed technology intangible asset in the second quarter of 2019. In addition, we are required to pay royalties and regulatory and sales milestone payments to Palatin as described in more detail above in Note P, “ Commitments and Contingencies. ” The Palatin License Agreement expires on the date of expiration of all royalty obligations due thereunder, unless earlier terminated in accordance with the Palatin License Agreement. |
Debt
Debt | 9 Months Ended |
Sep. 30, 2019 | |
Debt Disclosure [Abstract] | |
Debt | DEBT Our outstanding debt obligations as of September 30, 2019 and December 31, 2018 consisted of the following (in thousands): September 30, 2019 December 31, 2018 2022 Convertible Notes $ 273,124 $ 261,933 2019 Convertible Notes — 21,276 Total long-term debt 273,124 283,209 Less: current maturities — 21,276 Long-term debt, net of current maturities $ 273,124 $ 261,933 Convertible Notes The outstanding balance of our 2022 Convertible Notes as of September 30, 2019 consisted of the following (in thousands): 2022 Convertible Notes Liability component: Principal $ 320,000 Less: debt discount and issuance costs, net 46,876 Net carrying amount $ 273,124 Gross equity component $ 72,576 In accordance with accounting guidance for debt with conversion and other options, we separately account for the liability and equity components of our 2022 Convertible Notes by allocating the proceeds between the liability component and the embedded conversion option (the “Equity Component”) due to our ability to settle the 2022 Convertible Notes in cash, common stock or a combination of cash and common stock, at our option. The carrying amount of the liability component was calculated by measuring the fair value of a similar liability that does not have an associated convertible feature. The allocation was performed in a manner that reflected our non-convertible debt borrowing rate for similar debt. The Equity Component of the 2022 Convertible Notes was recognized as a debt discount and represents the difference between the proceeds from the issuance of the 2022 Convertible Notes and the fair value of the liability of the 2022 Convertible Notes on the date of issuance. The excess of the principal amount of the liability component over its carrying amount is amortized to interest expense using the effective interest method over five years . The Equity Component is not remeasured as long as it continues to meet the conditions for equity classification. 2022 Convertible Notes In the second quarter of 2017, we issued $320.0 million aggregate principal amount of convertible senior notes due in 2022 (the “2022 Convertible Notes”) and received net proceeds of $310.4 million from the sale of the 2022 Convertible Notes, after deducting fees and expenses of $9.6 million . The approximate $9.6 million of debt issuance costs primarily consisted of underwriting, legal and other professional fees, and we allocated these costs to the liability and equity components based on the allocation of the proceeds. Of the total $9.6 million of debt issuance costs, $2.2 million was allocated to the Equity Component and recorded as a reduction to additional paid-in capital and $7.4 million was allocated to the liability component and is now recorded as a reduction of the 2022 Convertible Notes on our condensed consolidated balance sheets. The portion allocated to the liability component is amortized to interest expense using the effective interest method over five years . The 2022 Convertible Notes are governed by the terms of an indenture between us, as issuer, and Wilmington Trust, National Association, as the trustee. The 2022 Convertible Notes are senior unsecured obligations and bear interest at a rate of 3.25% per year, payable semi-annually in arrears on June 1 and December 1 of each year, beginning on December 1, 2017. The 2022 Convertible Notes will mature on June 1, 2022 , unless earlier repurchased or converted. Upon conversion of the 2022 Convertible Notes, such 2022 Convertible Notes will be convertible into, at our election, cash, shares of our common stock, or a combination thereof, at a conversion rate of 36.5464 shares of common stock per $1,000 principal amount of the 2022 Convertible Notes, which corresponds to an initial conversion price of approximately $27.36 per share of our common stock. The conversion rate is subject to adjustment from time to time upon the occurrence of certain events, including, but not limited to, the issuance of stock dividends and payment of cash dividends. At any time prior to the close of business on the business day immediately preceding March 1, 2022, holders may convert their 2022 Convertible Notes at their option only under the following circumstances: 1) during any calendar quarter (and only during such calendar quarter), if the last reported sale price of our common stock for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending on the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the conversion price on each applicable trading day; 2) during the five business day period after any five consecutive trading day period (the “measurement period”) in which the trading price per $1,000 principal amount of the 2022 Convertible Notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price of our common stock and the conversion rate on each such trading day; or 3) upon the occurrence of specified corporate events. On or after March 1, 2022, until the close of business on the business day immediately preceding the maturity date, holders may convert all or any portion of their 2022 Convertible Notes, in multiples of $1,000 principal amount, at the option of the holder regardless of the foregoing circumstances. The 2022 Convertible Notes were not convertible as of September 30, 2019 . We determined the expected life of the debt was equal to the five-year term on the 2022 Convertible Notes. The effective interest rate on the liability component was 9.49% for the period from the date of issuance through September 30, 2019 . As of September 30, 2019 , the “if-converted value” did not exceed the remaining principal amount of the 2022 Convertible Notes. 2019 Convertible Notes In February 2014, we issued $200.0 million aggregate principal amount of the 2019 Convertible Notes. During 2017, we entered into privately negotiated transactions with certain investors to repurchase approximately $178.5 million aggregate principal amount of the 2019 Convertible Notes for an aggregate repurchase price of approximately $192.7 million , including accrued interest. The remaining $21.4 million of 2019 Convertible Notes matured on February 15, 2019 and were settled with cash. Convertible Notes Interest Expense The following table sets forth total interest expense recognized related to the Convertible Notes during the three and nine months ended September 30, 2019 and 2018 (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Contractual interest expense $ 2,600 $ 2,734 $ 7,867 $ 8,202 Amortization of debt issuance costs 353 355 1,051 1,040 Amortization of debt discount 3,466 3,391 10,281 9,942 Total interest expense $ 6,419 $ 6,480 $ 19,199 $ 19,184 Convertible Bond Hedge and Warrant Transactions In February 2014, we entered into convertible bond hedge transactions and separate warrant transactions of our common stock underlying the aggregate principal amount of the 2019 Convertible Notes with certain financial institutions (the “call spread counterparties”). In connection with the 2017 repurchases of the 2019 Convertible Notes, as discussed above, we entered into agreements with the call spread counterparties to terminate a portion of the then existing convertible bond hedge transactions in an amount corresponding to the amount of such 2019 Convertible Notes repurchased and to terminate a portion of the then-existing warrant transactions. In February 2019, the 2019 Convertible Notes matured and were settled with cash and the remaining bond hedge and warrant transactions expired. 2023 Senior Notes In August 2015, we completed a private placement of $500.0 million aggregate principal amount of 7.875% Senior Notes due 2023 (the “2023 Senior Notes”). The 2023 Senior Notes were issued pursuant to an Indenture, dated as of August 17, 2015 (the “Indenture”), by and among us, certain of our subsidiaries acting as guarantors of the 2023 Senior Notes and Wilmington Trust, National Association, as trustee. In October 2017, we repurchased $25.0 million of the 2023 Senior Notes in a privately negotiated transaction, resulting in a loss on extinguishment of debt of $1.1 million . In September 2018, we repurchased the remaining $475.0 million of the 2023 Senior Notes at a premium of $28.1 million using the proceeds from the CBR sale, which resulted in a loss on extinguishment of debt of $35.9 million , inclusive of the premium paid. Future Payments Future annual principal payments on our long-term debt as of September 30, 2019 were as follows (in thousands): Period Future Annual Principal Payments Remainder of Year Ending December 31, 2019 $ — Year Ending December 31, 2020 — Year Ending December 31, 2021 — Year Ending December 31, 2022 320,000 Year Ending December 31, 2023 — Thereafter — Total $ 320,000 |
Restructuring Expenses
Restructuring Expenses | 9 Months Ended |
Sep. 30, 2019 | |
Restructuring and Related Activities [Abstract] | |
Restructuring Expenses | RESTRUCTURING EXPENSES In February 2019, we completed a restructuring to combine our women’s health and maternal health sales forces into one integrated sales team, which will promote Intrarosa, the Makena auto-injector and Vyleesi. Approximately 110 employees were displaced through this workforce reduction. We recorded one-time restructuring charges of $7.4 million primarily related to severance and related benefits on our condensed consolidated statement of operations for the nine months ended September 30, 2019. We expect the restructuring charges incurred to date under this program to be substantially paid in cash by the end of the first quarter of 2020. The following table displays charges taken related to restructuring activities during the nine months ended September 30, 2019 and a rollforward of the changes to the accrued balances as of September 30, 2019 (in thousands): Workforce reduction Contract termination Other Total Balance accrued at December 31, 2018 $ — $ — $ — $ — 2019 restructuring charges 7,034 229 157 7,420 Payments (5,257 ) (229 ) (157 ) (5,643 ) Balance accrued at June 30, 2019 1,777 — — 1,777 Payments (579 ) — — (579 ) Balance accrued at September 30, 2019 $ 1,198 $ — $ — $ 1,198 |
Recently Issued and Proposed Ac
Recently Issued and Proposed Accounting Pronouncements | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Changes and Error Corrections [Abstract] | |
Recently Issued and Proposed Accounting Pronouncements | RECENTLY ISSUED AND PROPOSED ACCOUNTING PRONOUNCEMENTS From time to time, new accounting pronouncements are issued by FASB or other standard setting bodies that are adopted by us as of the specified effective date. In August 2018, the FASB issued ASU No. 2018-13, Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement (“ASU 2018-13”). This standard eliminates, adds and modifies certain disclosure requirements for fair value measurements as part of its disclosure framework project. ASU 2018-13 is effective for annual reporting periods beginning after December 15, 2019 and interim periods within those annual periods and early adoption is permitted. We are currently evaluating the impact of our adoption of ASU 2018-13 on our condensed consolidated financial statements. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). This standard requires entities to measure all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions and reasonable and supportable forecasts. ASU 2016-13 will be effective for us for fiscal years beginning on or after January 1, 2020, including interim periods within those annual reporting periods and early adoption is permitted. We are currently evaluating the impact of our adoption of ASU 2016-13 on our condensed consolidated financial statements. |
Recently Adopted Accounting Pro
Recently Adopted Accounting Pronouncements | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Changes and Error Corrections [Abstract] | |
Recently Adopted Accounting Pronouncements | RECENTLY ADOPTED ACCOUNTING PRONOUNCEMENTS In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) (“ASC 842”). This standard requires an entity to recognize on its balance sheet assets and liabilities associated with the rights and obligations created by leases with terms greater than twelve months. We adopted the standard effective January 1, 2019. We chose to apply the provisions of ASC 842 as of the effective date with no restatement of prior periods or cumulative adjustment to retained earnings. Upon adoption, we elected to utilize the package of transition practical expedients, which allowed us to carry forward prior conclusions related to whether any expired or existing contracts are or contain leases, the lease classification for any expired or existing leases and initial direct costs for existing leases. We also made accounting policy elections to not separate lease and non-lease components for our real estate lease and to not recognize leases with an initial term of twelve months or less within our condensed consolidated balance sheets and to recognize those lease payments on a straight-line basis on our condensed consolidated statements of income over the lease term. In preparation for adoption of the standard, we implemented internal controls to enable the preparation of financial information. The adoption of this standard resulted in the recognition of operating lease liabilities of $8.5 million and related ROU assets of $7.6 million on our condensed consolidated balance sheets as of January 1, 2019, but did not have an impact on our condensed consolidated statements of operations. In November 2018, the FASB issued ASU No. 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 (“ASU 2018-18”). This standard clarifies that certain transactions between participants in a collaborative arrangement should be accounted for under ASC 606 when the counterparty is a customer. In addition, ASU 2018-18 precludes an entity from presenting consideration from a transaction in a collaborative arrangement as revenue from contracts with customers if the counterparty is not a customer for that transaction. We adopted ASU 2018-18 during the first quarter of 2019 and applied the provisions of this update retrospectively to all contracts that were not completed as of the date of our initial adoption of ASC 606. The adoption of ASU 2018-18 did not have a material impact on our financial position or results of operations. |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation These condensed consolidated financial statements are unaudited and, in the opinion of management, include all adjustments necessary for a fair statement of our financial position and results of operations for the interim periods presented. Such adjustments consisted only of normal recurring items. The year-end condensed consolidated balance sheet data was derived from audited financial statements, but does not include all disclosures required by accounting principles generally accepted in the United States of America (“GAAP”). In accordance with GAAP for interim financial reports and the instructions for Form 10-Q and the rules of the Securities and Exchange Commission, certain information and footnote disclosures normally included in annual financial statements have been condensed or omitted. Our accounting policies are described in the Notes to the Consolidated Financial Statements in our Annual Report on Form 10-K for the year ended December 31, 2018 (our “Annual Report”). Interim results are not necessarily indicative of the results of operations for the full year. These interim financial statements should be read in conjunction with our Annual Report. In August 2018, we completed the sale of our wholly-owned subsidiary, CBR Acquisition Holdings Corp, and the Cord Blood Registry ® (“CBR”) business to GI Partners (“GI”), a private equity investment firm, pursuant to the June 14, 2018 Stock Purchase Agreement between us and affiliates of GI. As of June 30, 2018, our CBR business met the criteria for classification as a discontinued operation. All historical operating results for CBR are therefore reflected within discontinued operations in the consolidated statements of operations for the three and nine months ended September 30, 2018. For additional information, see Note C, “ Discontinued Operations. ” |
Principles of Consolidation | Principles of Consolidation The accompanying condensed consolidated financial statements include our accounts and the accounts of our wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. |
Use of Estimates and Assumptions | Use of Estimates and Assumptions The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make certain estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and the related disclosure of contingent assets and liabilities. The most significant estimates and assumptions are used to determine amounts and values of, but are not limited to: revenue recognition related to product and collaboration revenue; product sales allowances and accruals; allowance for doubtful accounts; marketable securities; inventory; acquisition date fair value and subsequent fair value estimates used to assess impairment of long-lived assets, including goodwill, in-process research and development (“IPR&D”) and other intangible assets; contingent consideration; debt obligations; certain accrued liabilities, including clinical trial accruals; income taxes, inclusive of valuation allowances; and equity-based compensation expense. Actual results could differ materially from those estimates. |
Concentrations and Significant Customer Information | Concentrations and Significant Customer Information We are currently dependent on a single supplier for Feraheme drug substance (produced in two separate facilities) as well as a single supplier for our Makena auto-injector product. We have been and may continue to be exposed to a significant loss of revenue from the sale of our products in the event that our suppliers and/or manufacturers are not able to fulfill demand for any reason. |
Revenue Recognition | Revenue Recognition Product revenues Effective January 1, 2018, we adopted the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”), using the modified retrospective transition method. Under ASC 606, we recognize revenue when our customer obtains control of promised goods or services in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of ASC 606, we perform the following five steps: a. Identify the contract(s) with a customer; b. Identify the performance obligations in the contract; c. Determine the transaction price; d. Allocate the transaction price to the performance obligations in the contract; and e. Recognize revenue when (or as) the performance obligations are satisfied. We only apply the five-step model to contracts when it is probable that we will collect the consideration we are entitled to in exchange for the goods or services we transfer to the customer. At contract inception, if the contract is determined to be within the scope of ASC 606, we assess the goods or services promised within each contract, determine those that are performance obligations, and assess whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Collaboration Revenues When we enter into collaboration agreements, we assess whether the agreements fall within the scope of ASC Topic 808, Collaborative Arrangements (“ASC 808”) based on whether the arrangements involve joint operating activities and whether both parties have active participation in the arrangement and are exposed to significant risks and rewards. To the extent that the arrangement falls within the scope of ASC 808, we assess whether the payments between us and our collaboration partner fall within the scope of other accounting literature. If we conclude that payments from the collaboration partner to us represent consideration from a customer, such as license fees and contract research and development activities, we account for those payments within the scope of ASC 606. However, if we conclude that our collaboration partner is not a customer for certain activities and associated payments, such as for certain collaborative research, development, manufacturing and commercial activities, we present such payments as a reduction of research and development expense or general and administrative expense, based on where we present the related underlying expense. Variable Consideration |
Leases | Leases Effective January 1, 2019, we adopted ASC Topic 842, Leases (“ASC 842”), and chose to apply the provisions of ASC 842 as of the effective date with no restatement of prior periods or cumulative adjustment to retained earnings. Upon adoption, we elected to utilize the package of transition practical expedients, which allowed us to carry forward prior conclusions related to whether any expired or existing contracts are or contain leases, the lease classification for any expired or existing leases and initial direct costs for existing leases. We also made accounting policy elections to not separate lease and non-lease components for our real estate lease and to not recognize leases with an initial term of twelve months or less within our condensed consolidated balance sheets and to recognize those lease payments on a straight-line basis on our condensed consolidated statements of income over the lease term. We did not have any material short-term leases accounted for under this policy during the six months ended September 30, 2019 . We determine if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets, current portion of operating lease liability, and long-term operating lease liability on our condensed consolidated balance sheets. ROU assets represent our right to use an underlying asset for the lease term and operating lease liabilities represent our obligation to make lease payments arising from the lease. ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at the commencement date. As our leases do not provide an implicit rate, we use our incremental borrowing rate based on the information available at the commencement date in determining the present value of future payments. Our incremental borrowing rate is determined based on an evaluation of our creditworthiness and the prevailing market rates for collateralized debt with maturity dates commensurate with the term of each lease. Our lease terms may include options to extend or terminate the lease when it is reasonably certain that we will exercise the option. Lease expense for operating leases is recognized on a straight-line basis over the lease term. The lease payments used to determine our ROU assets may include lease incentives, stated rent increases, and escalation clauses linked to rates of inflation when determinable and are recognized in our ROU assets on our condensed consolidated balance sheet. In addition, certain lease agreements contain lease and non-lease components. With the exception of our real estate leases, we separate lease payments for the identified assets from any non-lease payments included in the agreement. For our real estate leases, we account for the lease and non-lease components as a single lease component. Additionally, for vehicle and certain equipment leases, we apply a portfolio approach to effectively account for the related ROU assets and operating lease liabilities. |
Recently Issued, Proposed and Adopted Accounting Pronouncements | RECENTLY ISSUED AND PROPOSED ACCOUNTING PRONOUNCEMENTS From time to time, new accounting pronouncements are issued by FASB or other standard setting bodies that are adopted by us as of the specified effective date. In August 2018, the FASB issued ASU No. 2018-13, Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement (“ASU 2018-13”). This standard eliminates, adds and modifies certain disclosure requirements for fair value measurements as part of its disclosure framework project. ASU 2018-13 is effective for annual reporting periods beginning after December 15, 2019 and interim periods within those annual periods and early adoption is permitted. We are currently evaluating the impact of our adoption of ASU 2018-13 on our condensed consolidated financial statements. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). This standard requires entities to measure all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions and reasonable and supportable forecasts. ASU 2016-13 will be effective for us for fiscal years beginning on or after January 1, 2020, including interim periods within those annual reporting periods and early adoption is permitted. We are currently evaluating the impact of our adoption of ASU 2016-13 on our condensed consolidated financial statements. In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) (“ASC 842”). This standard requires an entity to recognize on its balance sheet assets and liabilities associated with the rights and obligations created by leases with terms greater than twelve months. We adopted the standard effective January 1, 2019. We chose to apply the provisions of ASC 842 as of the effective date with no restatement of prior periods or cumulative adjustment to retained earnings. Upon adoption, we elected to utilize the package of transition practical expedients, which allowed us to carry forward prior conclusions related to whether any expired or existing contracts are or contain leases, the lease classification for any expired or existing leases and initial direct costs for existing leases. We also made accounting policy elections to not separate lease and non-lease components for our real estate lease and to not recognize leases with an initial term of twelve months or less within our condensed consolidated balance sheets and to recognize those lease payments on a straight-line basis on our condensed consolidated statements of income over the lease term. In preparation for adoption of the standard, we implemented internal controls to enable the preparation of financial information. The adoption of this standard resulted in the recognition of operating lease liabilities of $8.5 million and related ROU assets of $7.6 million on our condensed consolidated balance sheets as of January 1, 2019, but did not have an impact on our condensed consolidated statements of operations. In November 2018, the FASB issued ASU No. 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 (“ASU 2018-18”). This standard clarifies that certain transactions between participants in a collaborative arrangement should be accounted for under ASC 606 when the counterparty is a customer. In addition, ASU 2018-18 precludes an entity from presenting consideration from a transaction in a collaborative arrangement as revenue from contracts with customers if the counterparty is not a customer for that transaction. We adopted ASU 2018-18 during the first quarter of 2019 and applied the provisions of this update retrospectively to all contracts that were not completed as of the date of our initial adoption of ASC 606. The adoption of ASU 2018-18 did not have a material impact on our financial position or results of operations. |
Basis of Presentation and Sum_3
Basis of Presentation and Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
Schedule of customers representing greater than 10% of revenue balances | The following table sets forth customers who represented 10% or more of our total revenues for the three and nine months ended September 30, 2019 and 2018 : Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 McKesson Corporation 38 % 25 % 37 % 26 % AmerisourceBergen Drug Corporation 28 % 24 % 28 % 26 % Cardinal Health 11 % <10% 12 % <10% |
Discontinued Operations (Tables
Discontinued Operations (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Net income from discontinued operations | The following is a summary of net income from discontinued operations for the three and nine months ended September 30, 2018 : Three Months Ended September 30, 2018 Nine Months Ended September 30, 2018 Service revenues, net $ 12,163 $ 71,217 Costs and expenses: Cost of services 1,576 12,559 Selling, general and administrative expenses 4,749 39,899 Total costs and expenses 6,325 52,458 Operating income 5,838 18,759 Other income — 114 Income from discontinued operations 5,838 18,873 Gain on sale of CBR business 89,581 89,581 Income tax (benefit) expense (98 ) 3,346 Net income from discontinued operations $ 95,517 $ 105,108 |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Revenue from Contract with Customer [Abstract] | |
Disaggregated revenue | The following table provides information about disaggregated revenue by products for the three and nine months ended September 30, 2019 and 2018 (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Product sales, net Feraheme $ 44,205 $ 36,963 $ 126,294 $ 99,796 Makena 34,272 80,221 96,464 275,377 Intrarosa 5,607 4,925 14,898 10,331 Other 23 129 156 302 Total product sales, net $ 84,107 $ 122,238 $ 237,812 $ 385,806 Total gross product sales were offset by product sales allowances and accruals for the three and nine months ended September 30, 2019 and 2018 as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Gross product sales $ 254,073 $ 238,856 $ 704,976 $ 776,458 Provision for product sales allowances and accruals: Contractual adjustments 144,108 93,213 381,633 290,896 Governmental rebates 25,858 23,405 85,531 99,756 Total 169,966 116,618 467,164 390,652 Product sales, net $ 84,107 $ 122,238 $ 237,812 $ 385,806 |
Product revenue allowance and accrual activity | The following table summarizes the product revenue allowance and accrual activity for the three and nine months ended September 30, 2019 (in thousands): Contractual Governmental Adjustments Rebates Total Balance at December 31, 2018 $ 57,199 $ 29,114 $ 86,313 Provisions related to current period sales 233,305 44,539 277,844 Adjustments related to prior period sales 4,200 15,134 19,334 Payments/returns relating to current period sales (176,392 ) (11,909 ) (188,301 ) Payments/returns relating to prior period sales (40,538 ) (36,362 ) (76,900 ) Balance at June 30, 2019 $ 77,774 $ 40,516 $ 118,290 Provisions related to current period sales 139,697 27,296 166,993 Adjustments related to prior period sales 4,475 (1,438 ) 3,037 Payments/returns relating to current period sales (117,780 ) (4,899 ) (122,679 ) Payments/returns relating to prior period sales (20,239 ) (2,611 ) (22,850 ) Balance at September 30, 2019 $ 83,927 $ 58,864 $ 142,791 |
Marketable Securities (Tables)
Marketable Securities (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of marketable securities | The following is a summary of our marketable securities as of September 30, 2019 and December 31, 2018 (in thousands): September 30, 2019 Gross Gross Estimated Amortized Unrealized Unrealized Fair Cost Gains Losses Value Short-term marketable securities:* Corporate debt securities $ 41,596 $ 130 $ (9 ) $ 41,717 Certificates of deposit 3,500 — — 3,500 U.S. treasury and government agency securities 6,247 — (3 ) 6,244 Commercial paper — — — — Total short-term marketable securities $ 51,343 $ 130 $ (12 ) $ 51,461 Long-term marketable securities:** Corporate debt securities $ 20,076 $ 207 $ — $ 20,283 Total long-term marketable securities 20,076 207 — 20,283 Total marketable securities $ 71,419 $ 337 $ (12 ) $ 71,744 * Represents marketable securities with a remaining maturity of less than one year. ** Represents marketable securities with a remaining maturity of one to three years classified as short-term on our condensed consolidated balance sheets. December 31, 2018 Gross Gross Estimated Amortized Unrealized Unrealized Fair Cost Gains Losses Value Short-term marketable securities:* Corporate debt securities $ 51,184 $ — $ (236 ) $ 50,948 U.S. treasury and government agency securities 7,647 — (34 ) 7,613 Commercial paper 3,995 — — 3,995 Certificates of deposit 12,000 — — 12,000 Total short-term marketable securities $ 74,826 $ — $ (270 ) $ 74,556 Long-term marketable securities:** Corporate debt securities $ 62,530 $ 52 $ (433 ) $ 62,149 U.S. treasury and government agency securities 2,742 — (32 ) 2,710 Certificates of deposit 1,500 — — 1,500 Total long-term marketable securities 66,772 52 (465 ) 66,359 Total marketable securities $ 141,598 $ 52 $ (735 ) $ 140,915 * Represents marketable securities with a remaining maturity of less than one year. ** Represents marketable securities with a remaining maturity of one to three years classified as short-term on our condensed consolidated balance sheets. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Fair Value Disclosures [Abstract] | |
Schedule of assets and liabilities measured at fair value on a recurring basis | The following tables represent the fair value hierarchy as of September 30, 2019 and December 31, 2018 , for those assets and liabilities that we measure at fair value on a recurring basis (in thousands): Fair Value Measurements at September 30, 2019 Using: Quoted Prices in Significant Active Markets for Significant Other Unobservable Identical Assets Observable Inputs Inputs Total (Level 1) (Level 2) (Level 3) Assets: Cash equivalents $ 25,047 $ 25,047 $ — $ — Marketable securities: Corporate debt securities 62,000 — 62,000 — U.S. treasury and government agency securities 6,244 — 6,244 — Certificates of deposit 3,500 — 3,500 — Commercial paper — — — — Total marketable securities $ 71,744 $ — $ 71,744 $ — Total assets $ 96,791 $ 25,047 $ 71,744 $ — Liabilities: Contingent consideration - MuGard $ 293 $ — $ — $ 293 Total liabilities $ 293 $ — $ — $ 293 Fair Value Measurements at December 31, 2018 Using: Quoted Prices in Significant Active Markets for Significant Other Unobservable Identical Assets Observable Inputs Inputs Total (Level 1) (Level 2) (Level 3) Assets: Cash equivalents $ 71,568 $ 71,568 $ — $ — Corporate debt securities 113,097 — 113,097 — U.S. treasury and government agency securities 10,323 — 10,323 — Certificates of deposit 13,500 — 13,500 — Commercial paper 3,995 — 3,995 — Total assets $ 212,483 $ 71,568 $ 140,915 $ — Liabilities: Contingent consideration - MuGard 359 — — 359 Total liabilities $ 359 $ — $ — $ 359 |
Inventories (Tables)
Inventories (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Inventory Disclosure [Abstract] | |
Schedule of major classes of inventories | Our major classes of inventories were as follows as of September 30, 2019 and December 31, 2018 (in thousands): September 30, 2019 December 31, 2018 Raw materials $ 8,814 $ 9,388 Work in process 5,784 5,932 Finished goods 14,046 11,371 Total inventories $ 28,644 $ 26,691 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Property, Plant and Equipment [Abstract] | |
Schedule of property and equipment, net | Property and equipment, net consisted of the following as of September 30, 2019 and December 31, 2018 (in thousands): September 30, 2019 December 31, 2018 Computer equipment and software $ 1,672 $ 1,637 Furniture and fixtures 1,705 1,737 Leasehold improvements 4,859 2,938 Laboratory and production equipment 6,538 6,000 Construction in progress 125 420 14,899 12,732 Less: accumulated depreciation (6,987 ) (5,211 ) Property and equipment, net $ 7,912 $ 7,521 |
Goodwill and Intangible Asset_2
Goodwill and Intangible Assets, Net (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of finite-lived intangible assets | As of September 30, 2019 and December 31, 2018 , our intangible assets consisted of the following (in thousands): September 30, 2019 December 31, 2018 Accumulated Cumulative Accumulated Cumulative Cost Amortization Impairments Net Cost Amortization Impairments Net Finite-lived intangible assets: Makena base technology $ 797,100 $ 400,496 $ 396,604 $ — $ 797,100 $ 400,495 $ 319,246 $ 77,359 Makena auto-injector developed technology 79,100 13,716 — 65,384 79,100 6,952 — 72,148 Intrarosa developed technology 77,655 15,193 — 62,462 77,655 10,129 — 67,526 Vyleesi developed technology 60,000 269 — 59,731 — — — — Total intangible assets $ 1,013,855 $ 429,674 $ 396,604 $ 187,577 $ 953,855 $ 417,576 $ 319,246 $ 217,033 |
Schedule of expected future annual amortization expense related to intangible assets | We expect amortization expense related to our finite-lived intangible assets to be as follows (in thousands): Estimated Amortization Period Expense Remainder of Year Ending December 31, 2019 $ 5,557 Year Ending December 31, 2020 22,229 Year Ending December 31, 2021 22,229 Year Ending December 31, 2022 22,229 Year Ending December 31, 2023 22,229 Thereafter 93,104 Total $ 187,577 |
Current Liabilities (Tables)
Current Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Payables and Accruals [Abstract] | |
Schedule of accrued expenses | Accrued expenses consisted of the following as of September 30, 2019 and December 31, 2018 (in thousands): September 30, 2019 December 31, 2018 Commercial rebates, fees and returns $ 127,138 $ 80,520 Professional, license, and other fees and expenses 18,964 23,242 Salaries, bonuses, and other compensation 17,498 22,482 Research and development expense 4,020 2,226 Interest expense 3,467 1,067 Restructuring expense 1,198 — Total accrued expenses $ 172,285 $ 129,537 |
Income Taxes (Tables)
Income Taxes (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Income Tax Disclosure [Abstract] | |
Schedule of effective income tax rate and income tax expense (benefit) | The following table summarizes our effective tax rate and income tax expense (benefit) from continuing operations for the three and nine months ended September 30, 2019 and 2018 (in thousands except for percentages): Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Effective tax rate (1 )% 4 % — % (40 )% Income tax expense (benefit) $ 232 $ (2,352 ) $ (26 ) $ 42,204 |
Accumulated Other Comprehensi_2
Accumulated Other Comprehensive Loss (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Equity [Abstract] | |
Schedule of changes in accumulated other comprehensive loss | The following table summarizes the changes in the accumulated balances of other comprehensive loss during the three and nine months ended September 30, 2019 and 2018 (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Beginning balance $ (3,032 ) $ (4,295 ) $ (3,985 ) $ (3,908 ) Holding (losses) gains associated with marketable securities arising during period, net of tax (167 ) 134 786 (253 ) Ending balance $ (3,199 ) $ (4,161 ) $ (3,199 ) $ (4,161 ) |
Earnings Per Share (Tables)
Earnings Per Share (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Earnings Per Share [Abstract] | |
Schedule of components of basic and diluted earnings per share | The components of basic and diluted earnings per share for the three and nine months ended September 30, 2019 and 2018 were as follows (in thousands, except per share data): Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Net loss from continuing operations $ (23,617 ) $ (64,678 ) $ (266,528 ) $ (148,592 ) Net income from discontinued operations — 95,517 — 105,108 Net (loss) income $ (23,617 ) $ 30,839 $ (266,528 ) $ (43,484 ) Weighted average common shares outstanding 33,906 34,492 34,058 34,339 Basic and diluted net (loss) income per share: Loss from continuing operations $ (0.70 ) $ (1.88 ) $ (7.83 ) $ (4.33 ) Income from discontinued operations — 2.77 — 3.06 Basic and diluted net (loss) income per share $ (0.70 ) $ 0.89 $ (7.83 ) $ (1.27 ) |
Schedule of anti-dilutive securities from computation of diluted net income (loss) per share | The following table sets forth the potential common shares issuable upon the exercise of outstanding options, the vesting of restricted stock units (“RSUs”), and the conversion of the Convertible Notes, which were excluded from our computation of diluted net loss per share because their inclusion would have been anti-dilutive (in thousands): Nine Months Ended September 30, 2019 2018 Options to purchase shares of common stock 3,988 3,700 Shares of common stock issuable upon the vesting of RSUs 1,645 1,135 Warrants — 1,008 2022 Convertible Notes 11,695 11,695 2019 Convertible Notes — 790 Total 17,328 18,328 |
Equity-Based Compensation (Tabl
Equity-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Share-based Payment Arrangement [Abstract] | |
Summary of details regarding stock option activity | The following table summarizes stock option activity for the nine months ended September 30, 2019 : 2019 Equity 2007 Equity 2013 Lumara Inducement Plan Plan Equity Plan Grants Total Outstanding at December 31, 2018 — 2,781,786 124,450 810,343 3,716,579 Granted 344,208 465,009 34,700 80,366 924,283 Exercised — (2,025 ) — — (2,025 ) Expired or terminated — (585,312 ) (26,275 ) (131,250 ) (742,837 ) Outstanding at September 30, 2019 344,208 2,659,458 132,875 759,459 3,896,000 |
Summary of details regarding restricted stock activity | The following table summarizes RSU activity for the nine months ended September 30, 2019 : 2019 Equity 2007 Equity 2013 Lumara Inducement Plan Plan Equity Plan Grants Total Outstanding at December 31, 2018 — 1,041,141 2,101 85,293 1,128,535 Granted 123,228 1,023,847 1,100 29,385 1,177,560 Vested — (354,563 ) (1,034 ) (44,909 ) (400,506 ) Expired or terminated (1,800 ) (250,968 ) — (7,500 ) (260,268 ) Outstanding at September 30, 2019 121,428 1,459,457 2,167 62,269 1,645,321 |
Schedule of equity-based compensation expense | Equity-based compensation expense for the three and nine months ended September 30, 2019 and 2018 consisted of the following (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Cost of product sales $ 225 $ 281 $ 626 $ 588 Research and development 691 568 2,051 1,896 Selling, general and administrative 4,058 4,202 11,039 12,149 Total equity-based compensation expense 4,974 5,051 13,716 14,633 Income tax effect — — — — After-tax effect of equity-based compensation expense $ 4,974 $ 5,051 $ 13,716 $ 14,633 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Operating lease maturity, after adoption of topic 842 | Future minimum payments under our non-cancelable operating leases as of September 30, 2019 are as follows (in thousands): Period Future Minimum Lease Payments Remainder of Year Ending December 31, 2019 $ 1,073 Year Ending December 31, 2020 4,081 Year Ending December 31, 2021 1,881 Year Ending December 31, 2022 583 Year Ending December 31, 2023 53 Thereafter — Total $ 7,671 Less: Interest 333 Operating lease liability $ 7,338 |
Operating lease maturity, before adoption of topic 842 | Under the prior lease guidance, future minimum payments under our non-cancellable leases as of December 31, 2018 were as follows (in thousands): Period Future Minimum Lease Payments Year Ending December 31, 2019 $ 5,119 Year Ending December 31, 2020 4,075 Year Ending December 31, 2021 1,034 Year Ending December 31, 2022 — Year Ending December 31, 2023 — Total $ 10,228 |
Acquisitions, Collaboration, _2
Acquisitions, Collaboration, License and Other Strategic Agreements (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Summary of assets acquired and liabilities assumed related to the asset acquisition | A summary of the assets and liabilities acquired in exchange for cash consideration of $60.8 million and $10.0 million that was deemed paid in connection with the cancellation of the convertible note, described above, is presented in the following table (in millions): Assets: Cash $ 2.6 Operating lease right-of-use asset 0.8 Property and equipment 1.4 IPR&D 74.9 $ 79.7 Liabilities: Accrued severance liabilities $ (1.7 ) Deferred revenue (6.4 ) Operating lease liability (0.8 ) $ (8.9 ) |
Debt (Tables)
Debt (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Debt Disclosure [Abstract] | |
Schedule of outstanding debt obligations | Our outstanding debt obligations as of September 30, 2019 and December 31, 2018 consisted of the following (in thousands): September 30, 2019 December 31, 2018 2022 Convertible Notes $ 273,124 $ 261,933 2019 Convertible Notes — 21,276 Total long-term debt 273,124 283,209 Less: current maturities — 21,276 Long-term debt, net of current maturities $ 273,124 $ 261,933 |
Schedule of outstanding convertible debt | The outstanding balance of our 2022 Convertible Notes as of September 30, 2019 consisted of the following (in thousands): 2022 Convertible Notes Liability component: Principal $ 320,000 Less: debt discount and issuance costs, net 46,876 Net carrying amount $ 273,124 Gross equity component $ 72,576 |
Schedule of total interest expense recognized related to the convertible debt | The following table sets forth total interest expense recognized related to the Convertible Notes during the three and nine months ended September 30, 2019 and 2018 (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Contractual interest expense $ 2,600 $ 2,734 $ 7,867 $ 8,202 Amortization of debt issuance costs 353 355 1,051 1,040 Amortization of debt discount 3,466 3,391 10,281 9,942 Total interest expense $ 6,419 $ 6,480 $ 19,199 $ 19,184 |
Schedule of future annual principal payments on long-term debt | Future annual principal payments on our long-term debt as of September 30, 2019 were as follows (in thousands): Period Future Annual Principal Payments Remainder of Year Ending December 31, 2019 $ — Year Ending December 31, 2020 — Year Ending December 31, 2021 — Year Ending December 31, 2022 320,000 Year Ending December 31, 2023 — Thereafter — Total $ 320,000 |
Restructuring Expenses (Tables)
Restructuring Expenses (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Restructuring and Related Activities [Abstract] | |
Schedule of components of restructuring expenses | The following table displays charges taken related to restructuring activities during the nine months ended September 30, 2019 and a rollforward of the changes to the accrued balances as of September 30, 2019 (in thousands): Workforce reduction Contract termination Other Total Balance accrued at December 31, 2018 $ — $ — $ — $ — 2019 restructuring charges 7,034 229 157 7,420 Payments (5,257 ) (229 ) (157 ) (5,643 ) Balance accrued at June 30, 2019 1,777 — — 1,777 Payments (579 ) — — (579 ) Balance accrued at September 30, 2019 $ 1,198 $ — $ — $ 1,198 |
Description of Business (Detail
Description of Business (Details) | 9 Months Ended |
Sep. 30, 2019product_candidate | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Number of product candidates | 2 |
Basis of Presentation and Sum_4
Basis of Presentation and Summary of Significant Accounting Policies - Restricted Cash (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Accounting Policies [Abstract] | ||
Restricted cash | $ 495 | $ 495 |
Basis of Presentation and Sum_5
Basis of Presentation and Summary of Significant Accounting Policies - Concentration and Significant Customer Information (Details) - facility | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | |
Revenue from Contract with Customer, Product and Service Benchmark | Customer Concentration Risk | McKesson Corporation | |||||
Concentrations and Significant Customer Information | |||||
Concentration risk | 38.00% | 25.00% | 37.00% | 26.00% | |
Revenue from Contract with Customer, Product and Service Benchmark | Customer Concentration Risk | AmerisourceBergen Drug Corporation | |||||
Concentrations and Significant Customer Information | |||||
Concentration risk | 28.00% | 24.00% | 28.00% | 26.00% | |
Revenue from Contract with Customer, Product and Service Benchmark | Customer Concentration Risk | Cardinal Health | |||||
Concentrations and Significant Customer Information | |||||
Concentration risk | 11.00% | 12.00% | |||
Accounts Receivable | Customer Concentration Risk | Two customers | |||||
Concentrations and Significant Customer Information | |||||
Concentration risk | 70.00% | ||||
Accounts Receivable | Customer Concentration Risk | Three customers | |||||
Concentrations and Significant Customer Information | |||||
Concentration risk | 73.00% | ||||
Feraheme | |||||
Concentrations and Significant Customer Information | |||||
Number of production facilities | 2 |
Discontinued Operations - Summa
Discontinued Operations - Summary of Net Income (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Costs and expenses: | ||||
Income from discontinued operations | $ 0 | $ 5,838 | $ 0 | $ 18,873 |
Gain on sale of CBR business | 0 | 89,581 | 0 | 89,581 |
Income tax (benefit) expense | 0 | (98) | 0 | 3,346 |
Net income from discontinued operations | $ 0 | 95,517 | $ 0 | 105,108 |
CBR business | Discontinued Operations, Held-for-sale or Disposed of by Sale | ||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
Service revenues, net | 12,163 | 71,217 | ||
Costs and expenses: | ||||
Cost of services | 1,576 | 12,559 | ||
Selling, general and administrative expenses | 4,749 | 39,899 | ||
Total costs and expenses | 6,325 | 52,458 | ||
Operating income | 5,838 | 18,759 | ||
Other income | 0 | 114 | ||
Income from discontinued operations | 5,838 | 18,873 | ||
Gain on sale of CBR business | 89,581 | 89,581 | ||
Income tax (benefit) expense | (98) | 3,346 | ||
Net income from discontinued operations | $ 95,517 | $ 105,108 |
Discontinued Operations - Narra
Discontinued Operations - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
Gain on sale of CBR business | $ 0 | $ 89,581 | $ 0 | $ 89,581 |
Transaction costs | $ 0 | 14,111 | ||
Discontinued Operations, Held-for-sale or Disposed of by Sale | CBR business | ||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
Capital expenditures | 1,600 | |||
Depreciation and amortization expense | 8,400 | |||
Gain on sale of CBR business | $ 89,581 | 89,581 | ||
Transaction costs | $ 14,100 |
Revenue Recognition - Disaggreg
Revenue Recognition - Disaggregated Revenue By Products (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Disaggregation of Revenue [Line Items] | ||||
Revenues | $ 84,131 | $ 122,238 | $ 238,043 | $ 385,881 |
Feraheme | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | 44,205 | 36,963 | 126,294 | 99,796 |
Makena | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | 34,272 | 80,221 | 96,464 | 275,377 |
Intrarosa | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | 5,607 | 4,925 | 14,898 | 10,331 |
Other | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | 23 | 129 | 156 | 302 |
Product Revenue | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | $ 84,107 | $ 122,238 | $ 237,812 | $ 385,806 |
Revenue Recognition - Total Gro
Revenue Recognition - Total Gross Product (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Provision for product sales allowances and accruals: | ||||
Revenues | $ 84,131 | $ 122,238 | $ 238,043 | $ 385,881 |
Product Revenue | ||||
Disaggregation of Revenue [Line Items] | ||||
Gross product sales | 254,073 | 238,856 | 704,976 | 776,458 |
Provision for product sales allowances and accruals: | ||||
Contractual adjustments | 144,108 | 93,213 | 381,633 | 290,896 |
Governmental rebates | 25,858 | 23,405 | 85,531 | 99,756 |
Total | 169,966 | 116,618 | 467,164 | 390,652 |
Revenues | $ 84,107 | $ 122,238 | $ 237,812 | $ 385,806 |
Revenue Recognition - Product R
Revenue Recognition - Product Revenue Allowance and Accrual Activity (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 9 Months Ended |
Sep. 30, 2019 | Jun. 30, 2019 | Sep. 30, 2019 | |
Contractual Adjustments | |||
Balance at Beginning of Period | $ 77,774 | $ 57,199 | $ 57,199 |
Provisions related to current period sales | 139,697 | 233,305 | |
Adjustments related to prior period sales | 4,475 | 4,200 | 8,700 |
Payments/returns relating to current period sales | (117,780) | (176,392) | |
Payments/returns relating to prior period sales | (20,239) | (40,538) | |
Balance at End of Period | 83,927 | 77,774 | 83,927 |
Governmental Rebates | |||
Balance at Beginning of Period | 40,516 | 29,114 | 29,114 |
Provisions related to current period sales | 27,296 | 44,539 | |
Adjustments related to prior period sales | (1,438) | 15,134 | 13,700 |
Payments/returns relating to current period sales | (4,899) | (11,909) | |
Payments/returns relating to prior period sales | (2,611) | (36,362) | |
Balance at End of Period | 58,864 | 40,516 | 58,864 |
Revenue, Allowance [Roll Forward] | |||
Balance at Beginning of Period | 118,290 | 86,313 | 86,313 |
Provisions related to current period sales | 166,993 | 277,844 | |
Adjustments related to prior period sales | 3,037 | 19,334 | |
Payments/returns relating to current period sales | (122,679) | (188,301) | |
Payments/returns relating to prior period sales | (22,850) | (76,900) | |
Balance at End of Period | $ 142,791 | $ 118,290 | $ 142,791 |
Revenue Recognition - Remaining
Revenue Recognition - Remaining Performance Obligation (Details) | Sep. 30, 2019 |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2019-07-01 | |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | |
Remaining performance obligation, period | 2 years |
Revenue Recognition - Narrative
Revenue Recognition - Narrative (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Jun. 30, 2019 | Sep. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | |
Disaggregation of Revenue [Line Items] | |||||
Adjustments related to prior period sales. Medicaid rebates | $ (1,438,000) | $ 15,134,000 | $ 13,700,000 | ||
Adjustments related to prior period sales, contractual adjustments | 4,475,000 | $ 4,200,000 | 8,700,000 | ||
Deferred revenue | 6,300,000 | 6,300,000 | $ 6,400,000 | ||
Current portion of deferred revenue | 1,128,000 | 1,128,000 | $ 0 | ||
Perosphere Pharmaceuticals Inc. | |||||
Disaggregation of Revenue [Line Items] | |||||
Potential milestone payment receivable, subject to FDA clearance | $ 34,800,000 | 34,800,000 | |||
Milestone payment received | $ 0 |
Marketable Securities (Details)
Marketable Securities (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | |
Short-term marketable securities: | |||||
Amortized Cost | $ 51,343,000 | $ 51,343,000 | $ 74,826,000 | ||
Gross Unrealized Gains | 130,000 | 130,000 | 0 | ||
Gross Unrealized Losses | (12,000) | (12,000) | (270,000) | ||
Estimated Fair Value | 51,461,000 | 51,461,000 | 74,556,000 | ||
Long-term marketable securities: | |||||
Amortized Cost | 20,076,000 | 20,076,000 | 66,772,000 | ||
Gross Unrealized Gains | 207,000 | 207,000 | 52,000 | ||
Gross Unrealized Losses | 0 | 0 | (465,000) | ||
Estimated Fair Value | 20,283,000 | 20,283,000 | 66,359,000 | ||
Amortized Cost | 71,419,000 | 71,419,000 | 141,598,000 | ||
Gross Unrealized Gains | 337,000 | 337,000 | 52,000 | ||
Gross Unrealized Losses | (12,000) | (12,000) | (735,000) | ||
Estimated Fair Value | 71,744,000 | 71,744,000 | 140,915,000 | ||
Other-than-temporary impairment losses | 0 | $ 0 | 0 | $ 0 | |
Corporate debt securities | |||||
Short-term marketable securities: | |||||
Amortized Cost | 41,596,000 | 41,596,000 | 51,184,000 | ||
Gross Unrealized Gains | 130,000 | 130,000 | 0 | ||
Gross Unrealized Losses | (9,000) | (9,000) | (236,000) | ||
Estimated Fair Value | 41,717,000 | 41,717,000 | 50,948,000 | ||
Long-term marketable securities: | |||||
Amortized Cost | 20,076,000 | 20,076,000 | 62,530,000 | ||
Gross Unrealized Gains | 207,000 | 207,000 | 52,000 | ||
Gross Unrealized Losses | 0 | 0 | (433,000) | ||
Estimated Fair Value | 20,283,000 | 20,283,000 | 62,149,000 | ||
Certificates of deposit | |||||
Short-term marketable securities: | |||||
Amortized Cost | 3,500,000 | 3,500,000 | 12,000,000 | ||
Gross Unrealized Gains | 0 | 0 | 0 | ||
Gross Unrealized Losses | 0 | 0 | 0 | ||
Estimated Fair Value | 3,500,000 | 3,500,000 | 12,000,000 | ||
Long-term marketable securities: | |||||
Amortized Cost | 1,500,000 | ||||
Gross Unrealized Gains | 0 | ||||
Gross Unrealized Losses | 0 | ||||
Estimated Fair Value | 1,500,000 | ||||
U.S. treasury and government agency securities | |||||
Short-term marketable securities: | |||||
Amortized Cost | 6,247,000 | 6,247,000 | 7,647,000 | ||
Gross Unrealized Gains | 0 | 0 | 0 | ||
Gross Unrealized Losses | (3,000) | (3,000) | (34,000) | ||
Estimated Fair Value | 6,244,000 | 6,244,000 | 7,613,000 | ||
Long-term marketable securities: | |||||
Amortized Cost | 2,742,000 | ||||
Gross Unrealized Gains | 0 | ||||
Gross Unrealized Losses | (32,000) | ||||
Estimated Fair Value | 2,710,000 | ||||
Commercial paper | |||||
Short-term marketable securities: | |||||
Amortized Cost | 0 | 0 | 3,995,000 | ||
Gross Unrealized Gains | 0 | 0 | 0 | ||
Gross Unrealized Losses | 0 | 0 | 0 | ||
Estimated Fair Value | $ 0 | $ 0 | $ 3,995,000 |
Fair Value Measurements - Asset
Fair Value Measurements - Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - Fair Value, Recurring - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Assets: | ||
Cash equivalents | $ 25,047 | $ 71,568 |
Marketable securities: | ||
Available-for-sale securities | 71,744 | |
Total assets | 96,791 | 212,483 |
Liabilities: | ||
Total liabilities | 293 | 359 |
Other | ||
Liabilities: | ||
Contingent consideration - MuGard | 293 | 359 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Assets: | ||
Cash equivalents | 25,047 | 71,568 |
Marketable securities: | ||
Available-for-sale securities | 0 | |
Total assets | 25,047 | 71,568 |
Liabilities: | ||
Total liabilities | 0 | 0 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Other | ||
Liabilities: | ||
Contingent consideration - MuGard | 0 | 0 |
Significant Other Observable Inputs (Level 2) | ||
Assets: | ||
Cash equivalents | 0 | 0 |
Marketable securities: | ||
Available-for-sale securities | 71,744 | |
Total assets | 71,744 | 140,915 |
Liabilities: | ||
Total liabilities | 0 | 0 |
Significant Other Observable Inputs (Level 2) | Other | ||
Liabilities: | ||
Contingent consideration - MuGard | 0 | 0 |
Significant Unobservable Inputs (Level 3) | ||
Assets: | ||
Cash equivalents | 0 | 0 |
Marketable securities: | ||
Available-for-sale securities | 0 | |
Total assets | 0 | 0 |
Liabilities: | ||
Total liabilities | 293 | 359 |
Significant Unobservable Inputs (Level 3) | Other | ||
Liabilities: | ||
Contingent consideration - MuGard | 293 | 359 |
Corporate debt securities | ||
Marketable securities: | ||
Available-for-sale securities | 62,000 | 113,097 |
Corporate debt securities | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Marketable securities: | ||
Available-for-sale securities | 0 | 0 |
Corporate debt securities | Significant Other Observable Inputs (Level 2) | ||
Marketable securities: | ||
Available-for-sale securities | 62,000 | 113,097 |
Corporate debt securities | Significant Unobservable Inputs (Level 3) | ||
Marketable securities: | ||
Available-for-sale securities | 0 | 0 |
U.S. treasury and government agency securities | ||
Marketable securities: | ||
Available-for-sale securities | 6,244 | 10,323 |
U.S. treasury and government agency securities | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Marketable securities: | ||
Available-for-sale securities | 0 | 0 |
U.S. treasury and government agency securities | Significant Other Observable Inputs (Level 2) | ||
Marketable securities: | ||
Available-for-sale securities | 6,244 | 10,323 |
U.S. treasury and government agency securities | Significant Unobservable Inputs (Level 3) | ||
Marketable securities: | ||
Available-for-sale securities | 0 | 0 |
Certificates of deposit | ||
Marketable securities: | ||
Available-for-sale securities | 3,500 | 13,500 |
Certificates of deposit | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Marketable securities: | ||
Available-for-sale securities | 0 | 0 |
Certificates of deposit | Significant Other Observable Inputs (Level 2) | ||
Marketable securities: | ||
Available-for-sale securities | 3,500 | 13,500 |
Certificates of deposit | Significant Unobservable Inputs (Level 3) | ||
Marketable securities: | ||
Available-for-sale securities | 0 | 0 |
Commercial paper | ||
Marketable securities: | ||
Available-for-sale securities | 0 | 3,995 |
Commercial paper | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Marketable securities: | ||
Available-for-sale securities | 0 | 0 |
Commercial paper | Significant Other Observable Inputs (Level 2) | ||
Marketable securities: | ||
Available-for-sale securities | 0 | 3,995 |
Commercial paper | Significant Unobservable Inputs (Level 3) | ||
Marketable securities: | ||
Available-for-sale securities | $ 0 | $ 0 |
Fair Value Measurements - Conti
Fair Value Measurements - Contingent Consideration (Details) $ in Millions | Jun. 06, 2013 | Sep. 30, 2018USD ($) | Sep. 30, 2019USD ($) |
Other | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Contingent consideration (minimum) | $ 0.3 | ||
Contingent consideration (up to) | $ 0.6 | ||
Contingent consideration period | 10 years | ||
Other | Measurement Input, Discount Rate | Fair Value, Recurring | Significant Unobservable Inputs (Level 3) | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Contingent consideration, measurement input | 0.13 | ||
Contingent Consideration | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Reduced fair value of contingent consideration liability | $ 49.2 |
Fair Value Measurements - Debt
Fair Value Measurements - Debt (Details) $ in Millions | Sep. 30, 2019USD ($) |
Senior Convertible Notes Due 2022 | Significant Other Observable Inputs (Level 2) | |
Debt | |
Fair value of debt | $ 265.6 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 8,814 | $ 9,388 |
Work in process | 5,784 | 5,932 |
Finished goods | 14,046 | 11,371 |
Total inventories | $ 28,644 | $ 26,691 |
Property and Equipment, Net (De
Property and Equipment, Net (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Property, plant and equipment, net | ||
Property and equipment, gross | $ 14,899 | $ 12,732 |
Less: accumulated depreciation | (6,987) | (5,211) |
Property and equipment, net | 7,912 | 7,521 |
Computer equipment and software | ||
Property, plant and equipment, net | ||
Property and equipment, gross | 1,672 | 1,637 |
Furniture and fixtures | ||
Property, plant and equipment, net | ||
Property and equipment, gross | 1,705 | 1,737 |
Leasehold improvements | ||
Property, plant and equipment, net | ||
Property and equipment, gross | 4,859 | 2,938 |
Laboratory and production equipment | ||
Property, plant and equipment, net | ||
Property and equipment, gross | 6,538 | 6,000 |
Construction in progress | ||
Property, plant and equipment, net | ||
Property and equipment, gross | $ 125 | $ 420 |
Goodwill and Intangible Asset_3
Goodwill and Intangible Assets, Net - Schedule of Intangible Assets (Details) - USD ($) | Sep. 30, 2019 | Jun. 30, 2019 | Dec. 31, 2018 |
Finite-lived intangible assets: | |||
Finite-lived intangible assets, cost | $ 1,013,855,000 | $ 953,855,000 | |
Finite-lived intangible assets, accumulated amortization | 429,674,000 | 417,576,000 | |
Finite-lived intangible assets, cumulative impairments | 396,604,000 | 319,246,000 | |
Total | 187,577,000 | 217,033,000 | |
Makena base technology | Developed Technology Rights | |||
Finite-lived intangible assets: | |||
Finite-lived intangible assets, cost | 797,100,000 | 797,100,000 | |
Finite-lived intangible assets, accumulated amortization | 400,496,000 | 400,495,000 | |
Finite-lived intangible assets, cumulative impairments | 396,604,000 | 319,246,000 | |
Total | 0 | $ 0 | 77,359,000 |
Makena auto-injector developed technology | Developed Technology Rights | |||
Finite-lived intangible assets: | |||
Finite-lived intangible assets, cost | 79,100,000 | 79,100,000 | |
Finite-lived intangible assets, accumulated amortization | 13,716,000 | 6,952,000 | |
Finite-lived intangible assets, cumulative impairments | 0 | 0 | |
Total | 65,384,000 | 72,148,000 | |
Intrarosa developed technology | Developed Technology Rights | |||
Finite-lived intangible assets: | |||
Finite-lived intangible assets, cost | 77,655,000 | 77,655,000 | |
Finite-lived intangible assets, accumulated amortization | 15,193,000 | 10,129,000 | |
Finite-lived intangible assets, cumulative impairments | 0 | 0 | |
Total | 62,462,000 | 67,526,000 | |
Vyleesi developed technology | Developed Technology Rights | |||
Finite-lived intangible assets: | |||
Finite-lived intangible assets, cost | 60,000,000 | 0 | |
Finite-lived intangible assets, accumulated amortization | 269,000 | 0 | |
Finite-lived intangible assets, cumulative impairments | 0 | 0 | |
Total | $ 59,731,000 | $ 0 |
Goodwill and Intangible Asset_4
Goodwill and Intangible Assets, Net - Narrative (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2019 | Jun. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | |
Finite-lived intangible assets: | ||||||
Milestone payment accrued for FDA approval of Vyleesi | $ 60,000,000 | |||||
Fair value of intangible asset | $ 187,577,000 | $ 187,577,000 | $ 217,033,000 | |||
Impairment of intangible assets | 0 | 77,400,000 | $ 0 | $ 77,358,000 | $ 0 | |
Expected useful life | 8 years 7 months 6 days | |||||
Amortization of intangible assets | $ 12,100,000 | $ 144,700,000 | ||||
Makena base technology | Developed Technology Rights | ||||||
Finite-lived intangible assets: | ||||||
Fair value of intangible asset | $ 0 | $ 0 | $ 0 | $ 77,359,000 |
Goodwill and Intangible Asset_5
Goodwill and Intangible Assets, Net - Schedule of Expected Future Annual Amortization Expense related to Intangible Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Estimated Amortization Expense | ||
Remainder of Year Ending December 31, 2019 | $ 5,557 | |
Year Ending December 31, 2020 | 22,229 | |
Year Ending December 31, 2021 | 22,229 | |
Year Ending December 31, 2022 | 22,229 | |
Year Ending December 31, 2023 | 22,229 | |
Thereafter | 93,104 | |
Total | $ 187,577 | $ 217,033 |
Current Liabilities (Details)
Current Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Payables and Accruals [Abstract] | ||
Commercial rebates, fees and returns | $ 127,138 | $ 80,520 |
Professional, license, and other fees and expenses | 18,964 | 23,242 |
Salaries, bonuses, and other compensation | 17,498 | 22,482 |
Research and development expense | 3,467 | 1,067 |
Interest expense | 4,020 | 2,226 |
Restructuring expense | 1,198 | 0 |
Total accrued expenses | $ 172,285 | $ 129,537 |
Income Taxes - Schedule of Effe
Income Taxes - Schedule of Effective Income Tax Rate and Income Tax Expense (Benefit) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Income Tax Disclosure [Abstract] | ||||
Effective tax rate | (1.00%) | 4.00% | 0.00% | (40.00%) |
Income tax expense (benefit) | $ 232 | $ (2,352) | $ (26) | $ 42,204 |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Income Tax Disclosure [Abstract] | ||||
Income tax expense (benefit) | $ 232 | $ (2,352) | $ (26) | $ 42,204 |
Effective tax rate | (1.00%) | 4.00% | 0.00% | (40.00%) |
Accumulated Other Comprehensi_3
Accumulated Other Comprehensive Loss (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
AOCI Attributable to Parent, Net of Tax | ||||
Beginning balance | $ 499,507 | $ 726,903 | $ 746,655 | $ 790,244 |
Holding (losses) gains associated with marketable securities arising during period, net of tax | (167) | 134 | 786 | (253) |
Ending balance | 480,628 | 762,246 | 480,628 | 762,246 |
Accumulated Other Comprehensive Loss | ||||
AOCI Attributable to Parent, Net of Tax | ||||
Beginning balance | (3,032) | (4,295) | (3,985) | (3,908) |
Ending balance | $ (3,199) | $ (4,161) | $ (3,199) | $ (4,161) |
Earnings Per Share (Details)
Earnings Per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Basic and Diluted Earnings per Share | ||||
Net loss from continuing operations | $ (23,617) | $ (64,678) | $ (266,528) | $ (148,592) |
Net income from discontinued operations | 0 | 95,517 | 0 | 105,108 |
Net (loss) income | $ (23,617) | $ 30,839 | $ (266,528) | $ (43,484) |
Weighted average common shares outstanding (in shares) | 33,906 | 34,492 | 34,058 | 34,339 |
Basic and diluted net (loss) income per share: | ||||
Loss from continuing operations (in dollars per share) | $ (0.70) | $ (1.88) | $ (7.83) | $ (4.33) |
Income from discontinued operations (in dollars per share) | 0 | 2.77 | 0 | 3.06 |
Basic and diluted net (loss) income per share (in dollars per share) | $ (0.70) | $ 0.89 | $ (7.83) | $ (1.27) |
Anti-dilutive securities (in shares) | 17,328 | 18,328 | ||
Options to purchase shares of common stock | ||||
Basic and diluted net (loss) income per share: | ||||
Anti-dilutive securities (in shares) | 3,988 | 3,700 | ||
Shares of common stock issuable upon the vesting of RSUs | ||||
Basic and diluted net (loss) income per share: | ||||
Anti-dilutive securities (in shares) | 1,645 | 1,135 | ||
Warrants | ||||
Basic and diluted net (loss) income per share: | ||||
Anti-dilutive securities (in shares) | 0 | 1,008 | ||
2022 Convertible Notes | Convertible Debt Securities | ||||
Basic and diluted net (loss) income per share: | ||||
Anti-dilutive securities (in shares) | 11,695 | 11,695 | ||
2019 Convertible Notes | Convertible Debt Securities | ||||
Basic and diluted net (loss) income per share: | ||||
Anti-dilutive securities (in shares) | 0 | 790 |
Equity-Based Compensation - Act
Equity-Based Compensation - Activity Related to Plans (Details) $ in Millions | 1 Months Ended | 9 Months Ended | |
Mar. 31, 2019 | Feb. 28, 2019shares | Sep. 30, 2019USD ($)planshares | |
Equity compensation plans | |||
Number of equity compensation plans | plan | 3 | ||
Stock Options | |||
Outstanding, beginning (in shares) | 3,716,579 | ||
Granted (in shares) | 924,283 | ||
Vested (in shares) | (2,025) | ||
Expired or terminated (in shares) | (742,837) | ||
Outstanding, ending (in shares) | 3,896,000 | ||
Restricted Stock Units | |||
Restricted Stock Units | |||
Outstanding (in shares) | 1,128,535 | ||
Granted (in shares) | 1,177,560 | ||
Vested (in shares) | (400,506) | ||
Expired or terminated (in shares) | (260,268) | ||
Outstanding (in shares) | 1,645,321 | ||
2019 Equity Incentive Plan | |||
Stock Options | |||
Outstanding, beginning (in shares) | 0 | ||
Granted (in shares) | 344,208 | ||
Vested (in shares) | 0 | ||
Expired or terminated (in shares) | 0 | ||
Outstanding, ending (in shares) | 344,208 | ||
2019 Equity Incentive Plan | Restricted Stock Units | |||
Restricted Stock Units | |||
Outstanding (in shares) | 0 | ||
Granted (in shares) | 123,228 | ||
Vested (in shares) | 0 | ||
Expired or terminated (in shares) | (1,800) | ||
Outstanding (in shares) | 121,428 | ||
2007 Equity Plan | |||
Stock Options | |||
Outstanding, beginning (in shares) | 2,781,786 | ||
Granted (in shares) | 465,009 | ||
Vested (in shares) | (2,025) | ||
Expired or terminated (in shares) | (585,312) | ||
Outstanding, ending (in shares) | 2,659,458 | ||
2007 Equity Plan | Restricted Stock Units | |||
Restricted Stock Units | |||
Outstanding (in shares) | 1,041,141 | ||
Granted (in shares) | 1,023,847 | ||
Vested (in shares) | (354,563) | ||
Expired or terminated (in shares) | (250,968) | ||
Outstanding (in shares) | 1,459,457 | ||
2007 Equity Plan | Performance Restricted Stock Units (RSUs) | |||
Restricted Stock Units | |||
Granted (in shares) | 365,591 | ||
Award vesting period | 3 years | ||
Maximum shares that may be issued (in shares) | 347,591 | ||
Fair value, performance- based RSUs | $ | $ 4.5 | ||
Compensation expense, period for recognition | 3 years | ||
2013 Lumara Equity Plan | |||
Stock Options | |||
Outstanding, beginning (in shares) | 124,450 | ||
Granted (in shares) | 34,700 | ||
Vested (in shares) | 0 | ||
Expired or terminated (in shares) | (26,275) | ||
Outstanding, ending (in shares) | 132,875 | ||
2013 Lumara Equity Plan | Restricted Stock Units | |||
Restricted Stock Units | |||
Outstanding (in shares) | 2,101 | ||
Granted (in shares) | 1,100 | ||
Vested (in shares) | (1,034) | ||
Expired or terminated (in shares) | 0 | ||
Outstanding (in shares) | 2,167 | ||
Inducement Grants | |||
Stock Options | |||
Outstanding, beginning (in shares) | 810,343 | ||
Granted (in shares) | 80,366 | ||
Vested (in shares) | 0 | ||
Expired or terminated (in shares) | (131,250) | ||
Outstanding, ending (in shares) | 759,459 | ||
Inducement Grants | Restricted Stock Units | |||
Restricted Stock Units | |||
Outstanding (in shares) | 85,293 | ||
Granted (in shares) | 29,385 | ||
Vested (in shares) | (44,909) | ||
Expired or terminated (in shares) | (7,500) | ||
Outstanding (in shares) | 62,269 |
Equity-Based Compensation - Equ
Equity-Based Compensation - Equity-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2019 | Mar. 31, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Equity-based compensation expense | |||||
Total equity-based compensation expense | $ 4,974 | $ 5,051 | $ 13,716 | $ 14,633 | |
Income tax effect | 0 | 0 | 0 | 0 | |
After-tax effect of equity-based compensation expense | 4,974 | 5,051 | 13,716 | 14,633 | |
Cost of product sales | |||||
Equity-based compensation expense | |||||
Total equity-based compensation expense | 225 | 281 | 626 | 588 | |
Research and development | |||||
Equity-based compensation expense | |||||
Total equity-based compensation expense | 691 | 568 | 2,051 | 1,896 | |
Selling, general and administrative | |||||
Equity-based compensation expense | |||||
Total equity-based compensation expense | $ 4,058 | $ 4,202 | $ 11,039 | $ 12,149 | |
Restructuring Charges | |||||
Equity-based compensation expense | |||||
Total equity-based compensation expense | $ 700 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) | 9 Months Ended | ||
Sep. 30, 2019 | Mar. 31, 2019 | Jan. 01, 2019 | |
Equity [Abstract] | |||
Share repurchase program, remaining authorized amount | $ 26,800,000 | $ 20,500,000 | |
Share repurchase program, authorized amount | $ 20,000,000 | $ 60,000,000 | |
Common stock repurchased and retired (in shares) | 1,074,800 | ||
Common stock repurchased and retired | $ 13,700,000 |
Commitments and Contingencies_2
Commitments and Contingencies (Details) - USD ($) $ in Thousands | Sep. 25, 2019 | Jan. 31, 2019 | Sep. 30, 2018 | Feb. 28, 2017 | Jan. 31, 2017 | Sep. 30, 2019 | Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Jan. 01, 2019 | Jun. 30, 2018 | Nov. 30, 2014 |
Commitments | ||||||||||||
Operating lease, liability | $ 7,338 | $ 7,338 | $ 7,338 | |||||||||
Operating lease, right-of-use asset | $ 6,642 | $ 6,642 | $ 6,642 | |||||||||
Weighted average remaining operating lease term | 2 years 1 month 6 days | 2 years 1 month 6 days | 2 years 1 month 6 days | |||||||||
Weighted average operating lease discount rate | 4.63% | 4.63% | 4.63% | |||||||||
Lease cost | $ 1,400 | $ 3,900 | ||||||||||
Operating cash outflows from operating leases | 4,200 | |||||||||||
Right-of-use asset obtained in exchange for lease obligations | 1,000 | |||||||||||
Minimum purchase commitments | 50,500 | 50,500 | $ 50,500 | |||||||||
Contingent consideration paid | $ 50 | $ 87 | ||||||||||
Amount of damages sought after by plaintiff | $ 50,000 | |||||||||||
Velo Bio, LLC | Regulatory Milestone Achievement | ||||||||||||
Commitments | ||||||||||||
Milestone payments | $ 5,000 | 5,000 | ||||||||||
Velo Bio, LLC | Regulatory Milestone Achievement, U.S.Food And Drug Administration Approval | ||||||||||||
Commitments | ||||||||||||
Milestone payments | 30,000 | 30,000 | ||||||||||
Velo Bio, LLC | Annual Sales Milestone Achievements | ||||||||||||
Commitments | ||||||||||||
Milestone payments | 240,000 | 240,000 | ||||||||||
Velo Bio, LLC | Commercial Milestone Payments | ||||||||||||
Commitments | ||||||||||||
Milestone payments | 10,000 | $ 10,000 | ||||||||||
Endoceutics, Inc. | Intrarosa | First Sales Milestone Achievement | ||||||||||||
Commitments | ||||||||||||
Potential milestone payment, triggering event, sales | $ 150,000 | |||||||||||
Future contingent payments (up to) | 15,000 | |||||||||||
Endoceutics, Inc. | Intrarosa | Second Sales Milestone Achievement | ||||||||||||
Commitments | ||||||||||||
Potential milestone payment, triggering event, sales | 300,000 | |||||||||||
Future contingent payments (up to) | 30,000 | |||||||||||
Endoceutics, Inc. | Intrarosa | Third Sales Milestone Achievement | ||||||||||||
Commitments | ||||||||||||
Potential milestone payment, triggering event, sales | 500,000 | |||||||||||
Future contingent payments (up to) | 850,000 | |||||||||||
Endoceutics, Inc. | Intrarosa | Tiered Royalties | ||||||||||||
Commitments | ||||||||||||
Potential milestone payment, triggering event, sales | $ 150,000 | |||||||||||
Royalty percentage, maximum | 25.00% | |||||||||||
Net sales threshold, future contingent payments | $ 1,000,000 | |||||||||||
Period after first commercial sale | 10 years | |||||||||||
Palatin Technologies, Inc. | Vyleesi Products | First Sales Milestone Achievement | ||||||||||||
Commitments | ||||||||||||
Potential milestone payment, triggering event, sales | $ 250,000 | |||||||||||
Future contingent payments (up to) | 25,000 | |||||||||||
Palatin Technologies, Inc. | Vyleesi Products | Regulatory Milestone Achievement, U.S.Food And Drug Administration Approval | ||||||||||||
Commitments | ||||||||||||
Future contingent payments (up to) | $ 60,000 | |||||||||||
Palatin Technologies, Inc. | Vyleesi Products | Tiered Royalties | ||||||||||||
Commitments | ||||||||||||
Period after first commercial sale | 10 years | |||||||||||
Palatin Technologies, Inc. | Vyleesi Products | Achievement of Certain Annual Sales Milestones over Course of License Agreement | ||||||||||||
Commitments | ||||||||||||
Future contingent payments (up to) | $ 300,000 | |||||||||||
Minimum | ||||||||||||
Commitments | ||||||||||||
Remaining operating lease term | 1 year | |||||||||||
Minimum | Velo Bio, LLC | Annual Sales Milestone Achievements | ||||||||||||
Commitments | ||||||||||||
Sales milestone targets | 300,000 | |||||||||||
Maximum | ||||||||||||
Commitments | ||||||||||||
Remaining operating lease term | 4 years | |||||||||||
Maximum | Velo Bio, LLC | Annual Sales Milestone Achievements | ||||||||||||
Commitments | ||||||||||||
Sales milestone targets | $ 900,000 | |||||||||||
Lumara Health Inc. | ||||||||||||
Commitments | ||||||||||||
Contingent consideration (up to) | $ 350,000 | |||||||||||
Business acquisition, contingent consideration, liability | $ 50,000 | |||||||||||
Lumara Health Inc. | Annual Net Sales Milestone | ||||||||||||
Commitments | ||||||||||||
Contingent consideration paid | 150,000 | |||||||||||
Accounting Standards Update 2016-02 | ||||||||||||
Commitments | ||||||||||||
Operating lease, liability | 7,300 | $ 7,300 | 7,300 | $ 8,500 | ||||||||
Operating lease, right-of-use asset | $ 6,600 | $ 6,600 | $ 6,600 | $ 7,600 | ||||||||
Perosphere Pharmaceuticals Inc. | ||||||||||||
Commitments | ||||||||||||
Contingent consideration (up to) | $ 365,000 | |||||||||||
Perosphere Pharmaceuticals Inc. | Regulatory Milestone Achievement | ||||||||||||
Commitments | ||||||||||||
Contingent consideration (up to) | $ 140,000 | |||||||||||
Credited percentage | 50.00% | |||||||||||
Perosphere Pharmaceuticals Inc. | Milestone Achievement, Approval By European Medicines Agency | ||||||||||||
Commitments | ||||||||||||
Contingent consideration (up to) | $ 40,000 | |||||||||||
Perosphere Pharmaceuticals Inc. | Sales Milestones Achievement | ||||||||||||
Commitments | ||||||||||||
Contingent consideration (up to) | 225,000 | |||||||||||
Perosphere Pharmaceuticals Inc. | First Sales Milestone Achievement | ||||||||||||
Commitments | ||||||||||||
Contingent consideration, milestone payment | 20,000 | |||||||||||
Potential milestone payment, triggering event, sales | $ 100,000 |
Commitments and Contingencies -
Commitments and Contingencies - Operating Leases Maturity, After Adoption of Topic 842 (Details) $ in Thousands | Sep. 30, 2019USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
Remainder of Year Ending December 31, 2019 | $ 1,073 |
Year Ending December 31, 2020 | 4,081 |
Year Ending December 31, 2021 | 1,881 |
Year Ending December 31, 2022 | 583 |
Year Ending December 31, 2023 | 53 |
Thereafter | 0 |
Total | 7,671 |
Less: Interest | 333 |
Operating lease liability | $ 7,338 |
Commitments and Contingencies_3
Commitments and Contingencies - Operating Leases Maturity, Before Adoption of Topic 842 (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
Year Ending December 31, 2019 | $ 5,119 |
Year Ending December 31, 2020 | 4,075 |
Year Ending December 31, 2021 | 1,034 |
Year Ending December 31, 2022 | 0 |
Year Ending December 31, 2023 | 0 |
Total | $ 10,228 |
Acquisitions, Collaboration, _3
Acquisitions, Collaboration, License and Other Strategic Agreements - Narrative (Details) - USD ($) | Jan. 16, 2019 | Apr. 03, 2017 | Jun. 30, 2019 | Jun. 30, 2018 | Feb. 28, 2017 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Mar. 31, 2019 | Sep. 30, 2017 |
Collaborative Agreements | |||||||||||
Payment for debt extinguishment | $ 0 | $ 28,054,000 | |||||||||
Endoceutics, Inc. | |||||||||||
Collaborative Agreements | |||||||||||
Consideration recorded | $ 83,500,000 | ||||||||||
Payments related to collaborative arrangement | $ 50,000,000 | ||||||||||
Number of shares issued under arrangement (in shares) | 600,000 | ||||||||||
Net shares issued in connection with license agreement, value | $ 13,500,000 | ||||||||||
IPR&D expense | 5,800,000 | ||||||||||
Palatin Technologies, Inc. | |||||||||||
Collaborative Agreements | |||||||||||
Payments related to collaborative arrangement | $ 60,000,000 | ||||||||||
Out-of-pocket expenses (up to) | $ 25,000,000 | ||||||||||
Intrarosa | Endoceutics, Inc. | |||||||||||
Collaborative Agreements | |||||||||||
Payments related to collaborative arrangement | $ 6,000,000 | ||||||||||
Out-of-pocket expenses (up to) | $ 20,000,000 | ||||||||||
Intrarosa | Endoceutics, Inc. | Developed Technology Rights | |||||||||||
Collaborative Agreements | |||||||||||
Finite-lived intangible assets | 77,700,000 | ||||||||||
Intrarosa | Endoceutics, Inc. | Delivery Of Intrarosa Launch Quantities | |||||||||||
Collaborative Agreements | |||||||||||
Payments related to collaborative arrangement | $ 10,000,000 | ||||||||||
Intrarosa | Endoceutics, Inc. | First Anniversary Of Closing | |||||||||||
Collaborative Agreements | |||||||||||
Payments related to collaborative arrangement | $ 10,000,000 | ||||||||||
Vyleesi Products | Palatin Technologies, Inc. | Regulatory Milestone Achievement, Acceptance by U.S.Food and Drug Administration of New Drug Application | |||||||||||
Collaborative Agreements | |||||||||||
Payments related to collaborative arrangement | $ 20,000,000 | ||||||||||
Vyleesi Products | Palatin Technologies, Inc. | Regulatory Milestone Achievement, U.S.Food And Drug Administration Approval | |||||||||||
Collaborative Agreements | |||||||||||
Payments related to collaborative arrangement | $ 60,000,000 | ||||||||||
Failure To Supply A Certain Percentage Of Product | Prasco, LLC | |||||||||||
Collaborative Agreements | |||||||||||
Failure to supply, penalties | $ 3,500,000 | ||||||||||
Perosphere Pharmaceuticals Inc. | |||||||||||
Collaborative Agreements | |||||||||||
Consideration recorded | $ 50,000,000 | ||||||||||
Payments of asset acquisitions | 40,000,000 | ||||||||||
Cancellation of convertible note | 10,000,000 | ||||||||||
Other liabilities | 6,200,000 | ||||||||||
Cash consideration | $ 60,800,000 | ||||||||||
Discount rate | 34.00% | ||||||||||
Perosphere Pharmaceuticals Inc. | Perosphere Convertible Note | Convertible Debt | |||||||||||
Collaborative Agreements | |||||||||||
Aggregate principal amount of debt issued | $ 10,000,000 | ||||||||||
Perosphere Pharmaceuticals Inc. | Perosphere Term Loan | Line of Credit | |||||||||||
Collaborative Agreements | |||||||||||
Payment for debt extinguishment | $ 12,000,000 |
Acquisitions, Collaboration, _4
Acquisitions, Collaboration, License and Other Strategic Agreements - Assets Acquired and Liabilities Assumed Related to the Business Combination (Details) - Perosphere Pharmaceuticals Inc. $ in Millions | Jan. 16, 2019USD ($) |
Assets: | |
Cash | $ 2.6 |
Operating lease right-of-use asset | 0.8 |
Property and equipment | 1.4 |
IPR&D | 74.9 |
Total Assets | 79.7 |
Liabilities: | |
Accrued severance liabilities | (1.7) |
Deferred revenue | (6.4) |
Operating lease liability | (0.8) |
Total Liabilities | $ (8.9) |
Debt - Schedule of Outstanding
Debt - Schedule of Outstanding Debt Obligations (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Debt Instrument [Line Items] | ||
Long-term debt | $ 273,124 | $ 283,209 |
Less: current maturities | 0 | 21,276 |
Long-term debt, net of current maturities | 273,124 | 261,933 |
Convertible Debt | 2022 Convertible Notes | ||
Debt Instrument [Line Items] | ||
Long-term debt | 273,124 | 261,933 |
Convertible Debt | 2019 Convertible Notes | ||
Debt Instrument [Line Items] | ||
Long-term debt | $ 0 | $ 21,276 |
Debt - Outstanding Convertible
Debt - Outstanding Convertible Note Balances (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Liability component: | ||
Principal | $ 320,000 | |
Long-term debt | 273,124 | $ 283,209 |
Convertible Debt | 2022 Convertible Notes | ||
Liability component: | ||
Principal | 320,000 | |
Less: debt discount and issuance costs, net | 46,876 | |
Long-term debt | 273,124 | $ 261,933 |
Gross equity component | $ 72,576 |
Debt - Convertible Notes (Detai
Debt - Convertible Notes (Details) | Feb. 15, 2019USD ($) | Jun. 30, 2017USD ($)day$ / shares | Sep. 30, 2019USD ($) | Sep. 30, 2018USD ($) | Dec. 31, 2017USD ($) | Feb. 28, 2014USD ($) |
Debt Instrument [Line Items] | ||||||
Extinguishment of debt | $ 21,417,000 | $ 0 | ||||
Convertible Notes due 2022 | Convertible Debt | ||||||
Debt Instrument [Line Items] | ||||||
Period of amortization of debt discount to interest expense using effective interest method | 5 years | 5 years | ||||
Aggregate principal amount of debt issued | $ 320,000,000 | |||||
Proceeds from 2022 Convertible Notes | 310,400,000 | |||||
Payment of convertible debt issuance costs | 9,600,000 | |||||
Debt issuance costs | 9,600,000 | |||||
Debt issuance costs, allocated to equity component | 2,200,000 | |||||
Debt issuance costs allocated to the liability component | $ 7,400,000 | |||||
Interest rate | 3.25% | |||||
Debt conversion ratio | 0.0365464 | |||||
Initial conversion price of convertible notes into common stock (in usd per share) | $ / shares | $ 27.36 | |||||
Debt term | 5 years | |||||
Effective interest rate on liability component | 9.49% | |||||
Convertible Notes due 2019 | Convertible Debt | ||||||
Debt Instrument [Line Items] | ||||||
Aggregate principal amount of debt issued | $ 200,000,000 | |||||
Repurchase amount | $ 178,500,000 | |||||
Repurchase price | $ 192,700,000 | |||||
Extinguishment of debt | $ 21,400,000 | |||||
Debt Instrument, Conversion, Period One | Convertible Notes due 2022 | Convertible Debt | ||||||
Debt Instrument [Line Items] | ||||||
Trading period | day | 20 | |||||
Consecutive trading period | day | 30 | |||||
Closing sales price of the entity's common stock that the conversion price must exceed or be equal in order for the notes to be convertible | 130.00% | |||||
Debt Instrument, Conversion, Period Two | Convertible Notes due 2022 | Convertible Debt | ||||||
Debt Instrument [Line Items] | ||||||
Consecutive trading period | day | 5 | |||||
Closing sales price of the entity's common stock that the conversion price must exceed or be equal in order for the notes to be convertible | 98.00% | |||||
Consecutive business days after any five consecutive trading day period during the note measurement period | day | 5 |
Debt - Total Interest Expense R
Debt - Total Interest Expense Recognized Related to the Convertible Notes (Details) - Convertible Debt - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Debt Instrument [Line Items] | ||||
Contractual interest expense | $ 2,600 | $ 2,734 | $ 7,867 | $ 8,202 |
Amortization of debt issuance costs | 353 | 355 | 1,051 | 1,040 |
Amortization of debt discount | 3,466 | 3,391 | 10,281 | 9,942 |
Total interest expense | $ 6,419 | $ 6,480 | $ 19,199 | $ 19,184 |
Debt - 2023 Senior Notes (Detai
Debt - 2023 Senior Notes (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2018 | Oct. 31, 2017 | Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Aug. 31, 2015 | |
Debt Instrument [Line Items] | |||||||
Loss on debt extinguishment | $ 0 | $ 35,922,000 | $ 0 | $ 35,922,000 | |||
Payment of premium on debt extinguishment | $ 0 | 28,054,000 | |||||
Senior Notes | Senior Notes Due 2023 | |||||||
Debt Instrument [Line Items] | |||||||
Aggregate principal amount of debt issued | $ 500,000,000 | ||||||
Interest rate | 7.875% | ||||||
Repurchase amount | $ 475,000,000 | $ 25,000,000 | $ 475,000,000 | $ 475,000,000 | |||
Loss on debt extinguishment | 35,900,000 | $ 1,100,000 | |||||
Payment of premium on debt extinguishment | $ 28,100,000 |
Debt - Future Payments (Details
Debt - Future Payments (Details) $ in Thousands | Sep. 30, 2019USD ($) |
Debt Disclosure [Abstract] | |
Remainder of Year Ending December 31, 2019 | $ 0 |
Year Ending December 31, 2020 | 0 |
Year Ending December 31, 2021 | 0 |
Year Ending December 31, 2022 | 320,000 |
Year Ending December 31, 2023 | 0 |
Thereafter | 0 |
Total | $ 320,000 |
Restructuring Expenses - Narrat
Restructuring Expenses - Narrative (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | 9 Months Ended | ||
Feb. 28, 2019employee | Sep. 30, 2019USD ($) | Sep. 30, 2018USD ($) | Jun. 30, 2019USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2018USD ($) | |
Restructuring and Related Activities [Abstract] | ||||||
Employees displaced through workforce reduction | employee | 110 | |||||
Restructuring charges | $ | $ 0 | $ 0 | $ 7,420 | $ 7,420 | $ 0 |
Restructuring Expenses - Compon
Restructuring Expenses - Components of Restructuring Expenses (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 9 Months Ended | |||
Sep. 30, 2019 | Jun. 30, 2019 | Sep. 30, 2018 | Jun. 30, 2019 | Sep. 30, 2019 | Sep. 30, 2018 | |
Restructuring Reserve [Roll Forward] | ||||||
Accrued restructuring, beginning of period | $ 1,777 | $ 0 | $ 0 | |||
Restructuring charges | 0 | $ 0 | 7,420 | 7,420 | $ 0 | |
Payments | $ (579) | (5,643) | ||||
Accrued restructuring, end of period | 1,198 | 1,777 | 1,777 | 1,198 | ||
Workforce reduction | ||||||
Restructuring Reserve [Roll Forward] | ||||||
Accrued restructuring, beginning of period | 1,777 | 0 | 0 | |||
Restructuring charges | 7,034 | |||||
Payments | (579) | (5,257) | ||||
Accrued restructuring, end of period | 1,198 | 1,777 | 1,777 | 1,198 | ||
Contract termination | ||||||
Restructuring Reserve [Roll Forward] | ||||||
Accrued restructuring, beginning of period | 0 | 0 | 0 | |||
Restructuring charges | 229 | |||||
Payments | 0 | (229) | ||||
Accrued restructuring, end of period | 0 | 0 | 0 | 0 | ||
Other | ||||||
Restructuring Reserve [Roll Forward] | ||||||
Accrued restructuring, beginning of period | 0 | 0 | 0 | |||
Restructuring charges | 157 | |||||
Payments | 0 | (157) | ||||
Accrued restructuring, end of period | $ 0 | $ 0 | $ 0 | $ 0 |
Recently Adopted Accounting P_2
Recently Adopted Accounting Pronouncements - Narrative (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Jan. 01, 2019 |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Operating lease, liability | $ 7,338 | |
Operating lease, right-of-use asset | 6,642 | |
Accounting Standards Update 2016-02 | ||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Operating lease, liability | 7,300 | $ 8,500 |
Operating lease, right-of-use asset | $ 6,600 | $ 7,600 |
Uncategorized Items - amag93019
Label | Element | Value |
Accounting Standards Update 2014-09 [Member] | ||
Cumulative Effect of New Accounting Principle in Period of Adoption | us-gaap_CumulativeEffectOfNewAccountingPrincipleInPeriodOfAdoption | $ 1,136,000 |
Accounting Standards Update 2014-09 [Member] | Retained Earnings [Member] | ||
Cumulative Effect of New Accounting Principle in Period of Adoption | us-gaap_CumulativeEffectOfNewAccountingPrincipleInPeriodOfAdoption | $ 1,136,000 |